Simplexa Flu AlB & RSV Direct Assay Kits — Class II medical device recall Z-1144-2014
Terminated recall by Focus Diagnostics Inc, reported 2014-03-12, distributed nationwide. Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the pote
| Recall number | Z-1144-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Focus Diagnostics Inc, Cypress, CA, United States |
| Recall initiated | 2014-02-04 |
| Classified | 2014-03-05 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2014-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, ES, IL, PT, SE, SI |
| Quantity | 2,175 kits |
| Reason classes | potency |
| Lot numbers | 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807 |
| Model numbers | MOL2650 |
Product
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
Reason for recall
Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.
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-1144-2014. 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.