# FDA recall Z-2409-2021

> **Versea Diagnostics LLC** · Class II · device recall initiated 2021-07-27.

## 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

## 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

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.

## Key facts

- **Recall number:** Z-2409-2021
- **Recalling firm:** Versea Diagnostics LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-27
- **Report date:** 2021-09-08
- **Termination date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tampa, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2409-2021

## Citation

> AI Analytics. FDA recall Z-2409-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2409-2021. Source: US FDA. Licensed CC0.

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