thejoe LumiQuick Diagnostics Inc.

LumiQuick Diagnostics Inc.: 80 FDA recall reports

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

80Reports

0Class I

0Ongoing

2014-04-16Most recent

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.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It 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

Class	Reports
Class II	80

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.

Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054

Z-1345-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054

Z-1372-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054

Z-1363-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Cocaine Test Card; LumiQuick. Santa Clara, CA 95054

Z-1375-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Cocaine Test Card; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054

Z-1386-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

EDDP Test Card; LumiQuick. Santa Clara, CA 95054

Z-1377-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: EDDP Test Card; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Barbiturate Strip; LumiQuick. Santa Clara, CA 95054

Z-1370-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Barbiturate Strip; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Ketamine Strip; LumiQuick,. Santa Clara, CA 95054

Z-1392-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Ketamine Strip; LumiQuick,. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054

Z-1396-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054

Z-1401-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054

Z-1359-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054

Z-1383-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Tramadol Strip; LumiQuick. Santa Clara, CA 95054

Z-1366-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Tramadol Strip; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054

Z-1343-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Amphetamine Strip; LumiQuick. Santa Clara, CA 95054

Z-1368-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Amphetamine Strip; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054

Z-1402-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Methadone Test Card; LumiQuick. Santa Clara, CA 95054

Z-1381-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Methadone Test Card; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

THC Test Card; LumiQuick,. Santa Clara, CA 95054

Z-1391-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: THC Test Card; LumiQuick,. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Legionella Test Card; LumiQuick, Santa Clara, CA 95054

Z-1347-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Legionella Test Card; LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054

Z-1361-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054

Z-1385-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054

Z-1351-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054

Z-1399-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054

Z-1350-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054

Z-1357-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054

Z-1348-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054

Z-1340-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054

Z-1394-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Morphine Strip (300); LumiQuick, Santa Clara, CA 95054

Z-1384-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Morphine Strip (300); LumiQuick, Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054

Z-1404-2014 · Class II · reported 2014-04-16 · Terminated

Why it was recalled: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Product: Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
Where it went: Distributed in the states of CA, FL, NJ, TX, and NY.
How much: ALL

Showing the 30 most recent of 80. 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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