Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;

Recall Insight

This FDA Devices action (record #Z-0234-2025) was formally reported on November 6, 2024, with the manufacturer initiating the action on September 12, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Molecular, Inc. is listed as the recalling firm, operating out of Des Plaines, IL. Federal records indicate 15068 units units are affected.

The documented reason for this recall is: 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 co… Distribution data in the federal record shows the product reached: 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, C…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.