FDA Device recall Z-0234-2025
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095 by Abbott Molecular, citing 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 Ki….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0234-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-12 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Molecular |
| Distribution | US |
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
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.
Identifiers
| code_info | a) REF 09N17-095, UDI/DI 00884999048591; b) REF 09N17-090, UDI/DI 00884999047945; c) REF 09N17-091, UDI/DI 00884999049277 All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0234-2025%22
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