FDA Device recall Z-1009-2022
Accula SARS-CoV-2 Test, REF: COV4100
- FDA Device
- Class I
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class I recall of Accula SARS-CoV-2 Test, REF: COV4100 by Mesa Biotech, citing SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1009-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-04-06 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mesa Biotech |
| Distribution | US |
Product
Accula SARS-CoV-2 Test, REF: COV4100
Reason
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Identifiers
| code_info | UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016 , P22010-001,…UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016 , P22010-001, P22010-030, P22024-026, P22024-032, P22026-007, P22026-013, P22026-017 , P22010-017, P22010-032, P22024-027, P22026-002, P22026-008, P22026-014, P22026-019 , P22010-019, P22024-021, P22024-028, P22026-004, P22026-009, P22026-015, P22032-011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1009-2022%22
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