Atellica IM SARS-CoV-2 Antigen Assay — Class II medical device recall Z-0195-2022
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2021-11-10, distributed nationwide. Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assay
| Recall number | Z-0195-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2021-09-22 |
| Classified | 2021-11-03 |
| Reported by FDA | 2021-11-10 |
| Terminated | 2022-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 149 kits |
| UPC / GTIN / UDI-DI | 00630414611846 |
| Lot numbers | 44989001, 60407003 |
| Expiration dates | 2021-03-22, 2021-10-07 |
Product
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Reason for recall
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
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-0195-2022. 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.