Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Apolipoprotein B is an in vitro diagnostic assay for the Recalled by Abbott Laboratories, Inc Due to An update to the Reagents and Specimen Collection...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Laboratories, Inc directly.
Affected Products
Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.
Quantity: 2,273 kits
Why Was This Recalled?
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Laboratories, Inc
Abbott Laboratories, Inc has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report