Z-2409-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- July 27, 2021
- Termination Date
- April 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 563,290 in total
Product Description
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests
Reason for Recall
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Distribution Pattern
US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.
Code Information
all lot codes