Recall Z-2409-2021
Versea Diagnostics LLC · initiated July 27, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: all lot codes
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Versea Diagnostics, LLC began distributing their "URGENT MEDICAL DEVICE RECALL" notices dated 7/14/2021 to their direct consignee on 7/27/2021 by email. The notices instructed the customers immediately discontinue use of these test and quarantine, discard, return, or destroy any unused tests. Confirm any results from these tests using a different EUA authorized test. Discontinue the use of these products if you do not hold the required CLLIA status. Acknowledge your receipt of this notice by completing the attached Response Form, scanning and emailing the completed form to: compliance@versea.com. VERSA Diagnostics, LLC will work with its Customers to either: Affirm their customers authorization to use these products through their CLIA Number and Status Coordinate the return of unused, unopened products to VERSA Diagnostics, LLC The distributors were directed to notify their customers. The firm is seeking return of unused products. If you have questions, please call 800-397-0670 or email us at compliance@versea.com. We are available Monday through Friday from 8:00 AM to 4:00 PM Eastern Time.
Details
- Recall number
- Z-2409-2021
- Initiated
- July 27, 2021
- Terminated
- April 10, 2024
- Product code
- QKO – Reagent, Coronavirus Serological
- Quantity
- 563,290 in total
- Distribution
- 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.
- Recalling firm
- Versea Diagnostics LLC, Tampa, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2407-2021 Class II | CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen…Products may have been distributed to customers other than laboratories certified under the Clinical… | 07/27/2021Terminated |
| Z-2408-2021 Class II | FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of…Products may have been distributed to customers other than laboratories certified under the Clinical… | 07/27/2021Terminated |
| Z-2410-2021 Class II | Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of…Products may have been distributed to customers other than laboratories certified under the Clinical… | 07/27/2021Terminated |