Biomerieux Inc

Biomerieux Inc: 422 FDA recall reports

Every medical device recall the FDA has published for Biomerieux Inc. The fault, and how the agency graded it.

422Reports
11Class I
119Ongoing
2026-07-15Most recent
11 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II408
Class I11
Class III3

By year reported

YearReports
201233
201321
20141
201514
201613
2017194
201813
20192
20205
20215
202222
202395
20241
20251
20262
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

VITEK 2 AST-N447 TEST KIT Product reference 424620

Z-2715-2026  ·  Class II  ·  reported 2026-07-15  ·  Ongoing

Why it was recalled
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Product
VITEK 2 AST-N447 TEST KIT Product reference 424620
Where it went
International distribution to the countries of Belgium and the Netherlands.
How much
45,900 cards

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o

Z-1236-2026  ·  Class II  ·  reported 2026-02-11  ·  Ongoing

Why it was recalled
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Product
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 ...
Where it went
Worldwide - US Nationwide distribution.
How much
2,668,954 total

VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automate

Z-2671-2025  ·  Class II  ·  reported 2025-10-08  ·  Ongoing

Why it was recalled
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Product
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
Where it went
International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.
How much
235269 cards
Class I

VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF

Z-1464-2024  ·  Class I  ·  reported 2024-05-01  ·  Ongoing

Why it was recalled
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Product
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721
Where it went
Worldwide
How much
49215 units

MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory in

Z-1201-2023  ·  Class II  ·  reported 2023-03-08  ·  Ongoing

Why it was recalled
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Product
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Where it went
US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
How much
19 systems

PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040

Z-0873-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
Where it went
US Nationwide distribution.
How much
1 unit

VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700

Z-0798-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
Where it went
US Nationwide distribution.
How much
10 units

VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

Z-0864-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
Where it went
US Nationwide distribution.
How much
4 units

PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012

Z-0839-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
Where it went
US Nationwide distribution.
How much
1 unit

VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437

Z-0837-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Where it went
US Nationwide distribution.
How much
15 units

ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218

Z-0817-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Where it went
US Nationwide distribution.
How much
N/A

ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449

Z-0829-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
Where it went
US Nationwide distribution.
How much
2 units

VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416

Z-0856-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Where it went
US Nationwide distribution.
How much
64 units

BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012

Z-0806-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
Where it went
US Nationwide distribution.
How much
2 units

ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401

Z-0827-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
Where it went
US Nationwide distribution.
How much
3 units

ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553

Z-0851-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
Where it went
US Nationwide distribution.
How much
2 units

ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348

Z-0863-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
Where it went
US Nationwide distribution.
How much
1 unit

ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560

Z-0852-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
Where it went
US Nationwide distribution.
How much
6 units

VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226

Z-0797-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
Where it went
US Nationwide distribution.
How much
2 units

PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851

Z-0803-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
Where it went
US Nationwide distribution.
How much
1 unit

API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

Z-0783-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
Where it went
US Nationwide distribution.
How much
5 unit

VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346

Z-0791-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
Where it went
US Nationwide distribution.
How much
13 units

VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425

Z-0857-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Where it went
US Nationwide distribution.
How much
50 units

VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893

Z-0814-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
Where it went
US Nationwide distribution.
How much
13 units

VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051

Z-0850-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
Where it went
US Nationwide distribution.
How much
26 units

PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049

Z-0844-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
Where it went
US Nationwide distribution.
How much
8 units

ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786

Z-0859-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
Where it went
US Nationwide distribution.
How much
1 unit

PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841

Z-0802-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
Where it went
US Nationwide distribution.
How much
84 units

ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046

Z-0846-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
Where it went
US Nationwide distribution.
How much
8 units

VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436

Z-0836-2023  ·  Class II  ·  reported 2023-01-11  ·  Ongoing

Why it was recalled
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Product
VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
Where it went
US Nationwide distribution.
How much
310 units

Showing the 30 most recent of 422. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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