Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF

FDA device recall Z-0233-2025 · posted 2024-10-29 · Open, Classified

Recall details

Recalling firm

Abbott Molecular, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

MAQ

Quantity affected

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, B

Date initiated

2024-09-12

Date posted

2024-10-29

Location

Des Plaines, IL