FDA recall, , Moderate risk
Abbott Determine HIV 1/2 Ag/Ab Combo
Abbott Diagnostics has noticed a negative trend in false positive complaints for Determine" HIV 1/2 Ag/Ab Combo 25T kits (Catalog 7D2648).
Summary by Recall Canary from the FDA notice
What happened
Abbott Diagnostics Scarborough, Inc. recalled Determine HIV 1/2 Ag/Ab Combo 25T kits, Catalog No. 7D2648, nationwide after noticing a negative trend in false positive complaints. Impacted lots have a higher occurrence of preliminary false positive results due to a subcomponent used in the manufacture of devices. The company began the recall on July 31, 2025, and the FDA added it to its Enforcement Report on June 24, 2026.
The recall covered 896,425 units distributed nationwide, including states such as Alabama, Alaska, Arizona, and others, as well as the Virgin Islands.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its model number matches.
Determine HIV 1/2 Ag/Ab Combo 25T
- Model number
- 7D2648
Recall details
- Company began the recall
- Sold in
Domestic: Nationwide Distribution. AL, AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, ID, IN, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Virgin Islands
- Company
- Abbott Diagnostics Scarborough, Inc.
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97376
- Recall number
- B-0052-2026
- Quantity recalled
- 896,425 units
All recalls from Abbott Diagnostics Scarborough, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
