EL-Anti-SARS-CoV-2 IgG Kit — Class II medical device recall Z-2382-2021
Terminated recall by Thera Test Laboratories, Inc., reported 2021-09-08, distributed nationwide. The cross-reactivity of the device may present an increased level of potential false positives. Submitted as E
| Recall number | Z-2382-2021 |
|---|---|
| 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 | 2020-10-05 |
| Classified | 2021-08-27 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2022-02-15 |
| Distributed | Nationwide (US) |
| Quantity | 19 kits |
| Lot numbers | 05204351, 05204368 |
| Model numbers | 104-130 |
| Expiration dates | 2021-05-01, 2021-05-19 |
Product
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Reason for recall
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
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-2382-2021. 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.