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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Alinity m HPV AMP Kit

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 Class 2 Device Recall Abbott Alinity m HPV AMP Kitsee related information
Date Initiated by FirmSeptember 12, 2024
Date PostedOctober 29, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0233-2025
Recall Event ID 95442
PMA NumberP230003 
Product Classification Kit, dna detection, human papillomavirus - Product Code MAQ
ProductAbbott 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
Code Information a) REF 09N15-095, UDI/DI 00884999048614; b) REF 09N15-090, UDI/DI 00884999047921; c) REF 09N15-091, UDI/DI 00884999049529; All Lots
FEI Number 3005248192
Recalling Firm/
Manufacturer		 Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information ContactRay Bastian
224-361-7000
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionAbbott issued an "Urgent Field Safety Notice" dated 9/11/2024 to its consignees on 09/12/2024 via FedEx priority overnight express. The notice explained the issue, potential impact, and provided the following information: "Necessary Actions " If you experience an increased incidence of Error Code 9198 (Positive control is non-reactive) while testing the Alinity m HR HPVor Alinity m STI assay, please contact Abbott Technical Support at 1-800-553-7042 Option 2 for additional troubleshooting information. " Complete and return the associated Customer Reply Form. If you have forwarded this product to any other laboratories, please also forward this letter and customer reply form to that laboratory. Review this information with laboratory personnel and retain this communication for future reference." If you have any questions regarding this communication, please contact your local Abbott representative or call: 1-224-361-7000.
Quantity in Commerce13318 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MAQ
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