Abbott Molecular, Inc. Recall: Abbott Alinity m HPV AMP Kit, used with the Alinity m Syste
Abbott Molecular, Inc. Recall: Abbott Alinity m HPV AMP Kit, used with the Alinity m Syste is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Abbott Molecular, Inc.; Product: Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c
| Recalling firm | Abbott Molecular, Inc. |
|---|---|
| Product | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR |
| Recall initiated | 20240912 |
| Recall number | Z-0233-2025 |
| Category | device |
| State | IL |
| Country | United States |
$29/mo
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