Simplexa Group A Strep Direct — Class I medical device recall Z-1274-2016
Terminated recall by Focus Diagnostics Inc, reported 2016-04-13, distributed nationwide. Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direc
| Recall number | Z-1274-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Focus Diagnostics Inc, Cypress, CA, United States |
| Recall initiated | 2016-02-10 |
| Classified | 2016-04-01 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, DE, DK, DO, EC, ES, FR, GB, IL, KW, SE, SI, TH |
| Quantity | 41 units |
| Serial numbers | 151870, 152359, 152535, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262, 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692 and 21 more |
| Model numbers | MOL1451, MOL1452, MOL1455, MOL2850 |
Product
Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
Reason for recall
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
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-1274-2016. 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.