CLASS II Device recall · Reported 16 Apr 2014 · FDA Enforcement Report

Ck-mb Test Card (serum) recalled by LumiQuick Diagnostics

LumiQuick Diagnostics is recalling Ck-mb Test Card (serum), distributed in California, Florida, New Jersey, New York, Texas. The recall was initiated on 4 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number: 75007, All lots

Quantity recalledALL

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1415-2014
FDA event ID: 67665
Recalling firm: LumiQuick Diagnostics, Santa Clara, CA
Classification: Class II
Status: Terminated
Recall initiated: 4 Mar 2014
FDA classified: 7 Apr 2014
Reported: 16 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Mar 2014	Recall initiated by company
7 Apr 2014	Classified by FDA	+34 days
16 Apr 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Product as listed by the FDA

CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054

Where it was distributed

Distributed in the states of CA, FL, NJ, TX, and NY.

California Florida New Jersey New York Texas

Questions about this recall

Why was it recalled?

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Which lots are affected?

Catalog number: 75007, All lots

Where was it sold?

Distributed in the states of CA, FL, NJ, TX, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

79 other products · FDA event 67665

This product is part of a recall event; the main page for the event is Adenovirus Antigen Test Card recalled by LumiQuick Diagnostics.

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014	CLASS II	Adenovirus Antigen Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Benzodiazepine Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Fecal Occult Blood Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Cocaine Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Morphine Strips (2000) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	EDDP Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Barbiturate Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Ketamine Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Oxycodone Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Methylphenidate Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Dengue NS1 Ag/IgG/M Ab Duo Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Methamphetamine Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Tramadol Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Salmonella typhi Antigen Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Salmonella	5 states
16 Apr 2014	CLASS II	Amphetamine Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Methylphenidate Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Methadone Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	THC Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Legionella Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	PSA Test Card (Serum) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Morphine Test Card (300) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Malaria pf Antigen Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Propoxyphene Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Malaria pf Antigen Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Malaria pf/pan Antigen Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA recalled	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Dengue IgG/IgM recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Buprenorphine Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Morphine Strip (300) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Fentanyl Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Tuberculosis Antibody Test Card Serum recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Ketamine Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Clonazepam Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	PSA Test Card (Whole Blood) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Troponin I test Card (serum) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	K2 (synthetic Marijuana) Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Tramadol Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Rotavirus Test Card LumiQuick, Santa Clara, CA recalled	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	H. Pylori Antibody Test Card (Whole Blood) LumiQuick recalled	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	PCP Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Methamphetamine Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Propoxyphene Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Syphilis Test Card Whole Blood(Serum) LumiQuick recalled	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Syphilis Test Card (Serum) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Ck-mb Test Card (Whole Blood) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Drugs of Abuse Panel Test Device recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Morphine Test Card (2000) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Alcohol Test, Saliva recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Salmonella typhi IgG/IgM Duo Test recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Salmonella	5 states
16 Apr 2014	CLASS II	Troponin I test Card (Whole Blood) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Myoglobin Test Card (Whole Blood) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	K2 (synthetic Marijuana) Test card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Benzodiazepine Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Cardiac Panel Test (Serum) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Fecal Occult Blood Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Barbiturate Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	MDMA/Ecstasy Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Malaria pan Antigen Test recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Fentanyl Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Fentanyl Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	MDMA/Ecstasy Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Strep A Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Amphetamine Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Buprenorphine Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Oxycodone Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Dengue NS1 Antigen Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Salmonella typhi/paratyphi Antigen Test recalled	LumiQuick Diagnostics	Salmonella	5 states
16 Apr 2014	CLASS II	Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA recalled	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Cardiac Panel Test Card (Whole Blood) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	EDDP Strip; LumiQuick. Santa Clara, CA recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA recalled	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA recalled	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Myoglobin Test Card (Serum) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Cocaine Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Adeno/Rota Combo Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	THC Strip; LumiQuick,. Santa Clara, CA recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Alcohol Test, Urine recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	PCP Test (Strip) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014	CLASS II	Methadone Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states

More recalls from LumiQuick Diagnostics

All 80

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014Device	CLASS II	Methadone Test Strip recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014Device	CLASS II	PCP Test (Strip) recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014Device	CLASS II	Alcohol Test, Urine recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014Device	CLASS II	THC Strip; LumiQuick,. Santa Clara, CA recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states
16 Apr 2014Device	CLASS II	Adeno/Rota Combo Test Card recalled by LumiQuick Diagnostics	LumiQuick Diagnostics	Other	5 states

Other Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
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