Quidel — Class II medical device recall Z-0819-2013
Terminated recall by Quidel Corporation, reported 2013-02-20, distributed nationwide. Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits becau
| Recall number | Z-0819-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, San Diego, CA, United States |
| Recall initiated | 2012-12-03 |
| Classified | 2013-02-14 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2014-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CL, CN, DE, GB, HK, JP, KR, NL, NO, TH |
Product
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Reason for recall
Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
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-0819-2013. 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.