Reported Jul 1, 2026 · Ongoing · Updated Sep 16, 2026
Determine HIV 1/2 Ag/Ab Combo 25T, Model/Catalog No. 7D2648
Abbott Diagnostics Scarborough, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Diagnostics Scarborough, Inc. · 10 Southgate Rd · Scarborough, ME · 04074-8303
Is this the product you have?
Determine HIV 1/2 Ag/Ab Combo 25TModel/Catalog No. 7D2648
- Lot codes and dates
- Kit Lot # UDI EXPIRY 851700 010081187701110110851700 2025 12 04 867175 010081187701110110867175 2026 02 28 869145 010081187701110110869145 2026 02 28 871699 010081187701110110871699 2026 02 28 871729 010081187701110110871729 2026 02 28 874643 010081187701110110874643 2026 02 28 0000927861 0100811877011101100000927861 2026 05 28 0000927862 0100811877011101100000927862 2026 05 28 0000927863 0100811877011101100000927863 2026 07 28 0000929961 0100811877011101100000929961 2026 07 28 0000930922 0100811877011101100000930922 2026 07 28 0000930923 0100811877011101100000930923 2026 09 28 0000939868 0100811877011101100000939868 2026 09 28 0000946267 0100811877011101100000946267 2026 09 28 0000950115 0100811877011101100000950115 2026 09 28 0000950116 0100811877011101100000950116 2026 10 10 0000952264 0100811877011101100000952264 2026 10 28 0000952265 0100811877011101100000952265 2026 10 03 0000984187 0100811877011101100000984187 2026 03 29 0000990023 0100811877011101100000990023 2026 03 29 0000962456 0100811877011101100000962456 2026 10 28 0000962457 0100811877011101100000962457 2026 10 28
- Amount recalled
- 896,425 units
Where it was sold
Why it was recalled
Abbott Diagnostics has noticed a negative trend in false positive complaints for Determine" HIV 1/2 Ag/Ab Combo 25T kits (Catalog 7D2648). Impacted lots have a higher occurrence of preliminary false positive results due to a subcomponent used in the manufacture of devices.
This product could cause temporary or reversible health problems — stop using it.
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