EL-Anti-SARS-CoV-2 IgM Kit — Class II medical device recall Z-2381-2021
Terminated recall by Thera Test Laboratories, Inc., reported 2021-09-08, distributed nationwide. Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately v
| Recall number | Z-2381-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thera Test Laboratories, Inc., Lombard, IL, United States |
| Recall initiated | 2020-07-30 |
| Classified | 2021-08-27 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2022-02-15 |
| Distributed | Nationwide (US) |
| Quantity | 11 kits |
| Lot numbers | 05204350, 05204367, 06204432 |
| Model numbers | 104-129 |
| Expiration dates | 2021-05-01, 2021-05-19 |
Product
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Reason for recall
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2381-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.