Accula SARS-CoV-2 Test — Class I medical device recall Z-1009-2022
Ongoing recall by MESA BIOTECH, INC, reported 2022-05-18, distributed nationwide. SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct di
| Recall number | Z-1009-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MESA BIOTECH, INC, San Diego, CA, United States |
| Recall initiated | 2022-04-06 |
| Classified | 2022-05-06 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 6,162 |
| Model numbers | COV4100 |
Product
Accula SARS-CoV-2 Test, REF: COV4100
Reason for recall
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
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-1009-2022. 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.