Recall record at a glance
| Official record | Z-1125-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Confirm Biosciences Inc. |
| Report date | Feb 24, 2021 |
| Recall initiation date | Jan 29, 2021 |
| Quantity | 563,840 cassettes |
| Location | San Diego, CA, United States |
Official product description
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.
Why the product was recalled
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).
Distribution information
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Mexico, Honduras, Spain, Sierra Leone, Bahamas, Ecuador, Turkey, Romania, Kuwait, Libya, Qatar, Ghana, Argentina, Bolivia, Brazil, Guatemala, Panama, India, United Kingdom, West Indies, South Africa, United Arab Emirates, Slovenia, Canada, Israel, United Kingdom, Romania, Argentina, Honduras, Russian Federation, R¿publique D¿mocratique du Congo, Switzerland, Dominican Republic, Greece, Saudi Arabia, and Portugal.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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