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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: April 7, 2014
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Affected Products

Product: Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054

Catalog number: 71015, All lots

Product: Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054

Catalog number: 71016, All lots

Product: Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054

Catalog number: 71017, All lots

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

Catalog number: 71019, All lots

Product: H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054

Catalog number: 71020, All lots

Product: H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054

Catalog number: 71024, All lots

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

Catalog number: 71028, All lots

Product: Rotavirus Test Card LumiQuick, Santa Clara, CA 95054

Catalog number: 71029, All lots

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

Catalog number: 71032, All lots

Product: Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054

Catalog number: 71033, All lots

Product: Legionella Test Card; LumiQuick, Santa Clara, CA 95054

Catalog number: 71034, All lots

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

Catalog number: 71046, All lots

Product: Strep A Test Card; LumiQuick, Santa Clara, CA 95054

Catalog number: 71048, All lots

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

Catalog number: 71049, All lots

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

Catalog number: 71050, All lots

Product: Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054

Catalog number: 71053, All lots

Product: Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054

Catalog number: 71054, All lots

Product: Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054

Catalog number: 71055, All lots

Product: Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054

Catalog number: 71057, All lots

Product: Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054

Catalog number: 71062, All lots

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

Catalog number: 71063, All lots

Product: Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 71066, All lots

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

Catalog number: 71087, All lots

Product: Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 72001, All lots

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

Catalog number: 72003, All lots

Product: PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054

Catalog number: 72004, All lots

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

Catalog number: 72006, All lots

Product: Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054

Catalog number: 74001, All lots

Product: Tramadol Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74002, All lots

Product: Tramadol Strip; LumiQuick. Santa Clara, CA 95054

Catalog number: 74003, All lots

Product: Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054

Catalog number: 74007, All lots

Product: Amphetamine Strip; LumiQuick. Santa Clara, CA 95054

Catalog number: 74013, All lots

Product: Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74014, All lots

Product: Barbiturate Strip; LumiQuick. Santa Clara, CA 95054

Catalog number: 74015, All lots

Product: Barbiturate Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74016, All lots

Product: Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054

Catalog number: 74017, All lots

Product: Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74018, All lots

Product: Cocaine Strip; LumiQuick. Santa Clara, CA 95054

Catalog number: 74019, All lots

Product: Cocaine Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74020, All lots

Product: EDDP Strip; LumiQuick. Santa Clara, CA 95054

Catalog number: 74021, All lots

Product: EDDP Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74022, All lots

Product: MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054

Catalog number: 74023, All lots

Product: MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74024, All lots

Product: Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74025, All lots

Product: Methadone Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74026, All lots

Product: Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054

Catalog number: 74027, All lots

Product: Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054

Catalog number: 74028, All lots

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

Catalog number: 74029, All lots

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

Catalog number: 74030, All lots

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

Catalog number: 74031, All lots

Product: Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054

Catalog number: 74032, All lots

Product: PCP Test (Strip); LumiQuick, Santa Clara, CA 95054

Catalog number: 74033, All lots

Product: PCP Test Card; LumiQuick. Santa Clara, CA 95054

Catalog number: 74034, All lots

Product: THC Strip; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74035 All lots

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

Catalog number: 74036 All lots

Product: Ketamine Strip; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74039 All lots

Product: Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74040 All lots

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

Catalog number: 74041 All lots

Product: Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74042, All lots

Product: Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74043, All lots

Product: Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74044, All lots

Product: Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74049, All lots

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

Catalog number: 74051, All lots

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

Catalog number: 74052, All lots

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

Catalog number: 74055, All lots

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

Catalog number: 74056, All lots

Product: Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74057, All lots

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

Catalog number: 74058, All lots

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

Catalog number: 74059, All lots

Product: Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74060, All lots

Product: K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74065, All lots

Product: K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054

Catalog number: 74066, All lots

Product: Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054

Catalog number: 75001, All lots

Product: Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

Catalog number: 75002, All lots

Product: Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054

Catalog number: 75003, All lots

Product: Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

Catalog number: 75004, All lots

Product: Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054

Catalog number: 75005, All lots

Product: Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

Catalog number: 75006, All lots

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

Catalog number: 75007, All lots

Product: CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

Catalog number: 75008, All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 67665
Status: Resolved
Manufacturer: LumiQuick Diagnostics Inc.
Manufactured In: United States
Units Affected: 80 products (ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL; ALL)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.