Abbott Alinity m STI AMP Kit — Class II medical device recall Z-0234-2025
Ongoing recall by Abbott Molecular, Inc., reported 2024-11-06, distributed nationwide. Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reacti
| Recall number | Z-0234-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2024-09-12 |
| Classified | 2024-10-28 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BG, CA, CH, CR, CZ, DE, EE, ES, FI, FR, GB, GR, HR, IE, IL, IT, KE, LU, MA, MY, NL, NO, PL, PT, RO, SE, SG, SI, SV, TH, VN, ZA |
| Quantity | 15,068 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00884999047945, 00884999048591, 00884999049277 |
| Model numbers | 09N17-090, 09N17-091, 09N17-095 |
Product
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Reason for recall
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
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-0234-2025. 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.