Z-0233-2025Class II

Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF...

Name: Z-0233-2025 Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF...
Creator: Abbott Molecular, Inc.
Published: 2024-09-12
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2024-09-12 / Open, Classified / root cause: design

FDA source

Abbott Molecular, Inc. began a recall of 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 on 2024-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0233-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-12
Posted: 2024-10-29
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
Product code: MAQ Kit, Dna Detection, Human Papillomavirus
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.
Root cause tag: design
FDA root cause: Device Design
Action: Abbott 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 commerce: 13318 units
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, 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.
Product codes and lots: a) REF 09N15-095, UDI/DI 00884999048614; b) REF 09N15-090, UDI/DI 00884999047921; c) REF 09N15-091, UDI/DI 00884999049529; All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0233-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0233-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-28
Z-0234-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-28

Product code MAQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)