Abbott Molecular, Inc. 2024-11-06 Health serious FDA
Health · FDA · Recall #FDA-Z-0233-2025
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF… Recall
Issued November 6, 2024 · Abbott Molecular, Inc.
In November 2024, Abbott Molecular, Inc. recalled the Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abbott Molecular, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Abbott Molecular, Inc.
- Category
- Health
- Recall date
- November 6, 2024
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-0233-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Abbott Molecular, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.