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
Enforcement
- Recall Number
- Z-0233-2025
- Event ID
- 95442
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abbott Molecular, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 6, 2024
- Initiation Date
- September 12, 2024
- Classification Date
- October 28, 2024
- Address
- 1300 E Touhy Ave, N/A, Des Plaines, IL, 60018-3315, United States
Description
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
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.
a) REF 09N15-095, UDI/DI 00884999048614; b) REF 09N15-090, UDI/DI 00884999047921; c) REF 09N15-091, UDI/DI 00884999049529; All Lots
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, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, KAZAKHSTAN, KENYA, LUXEMBOURG, MALAWI, MALAYSIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TANZANIA, THAILAND, UNITED KINGDOM, AND VIETNAM.
13318 units