Abbott Apolipoprotein B Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 2,273 Apolipoprotein B in vitro diagnostic kits because the Instructions for Use (IFU) required updates to reagent and specimen handling sections.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the issue is a documentation update (IFU) rather than a direct physical defect or reported injury, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Abbott Laboratories, Inc. is recalling 2,273 kits of the Apolipoprotein B in vitro diagnostic assay. This product is used for the quantitative determination of apolipoprotein B in human serum or plasma. The recall was initiated because an update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the Instructions for Use (IFU) was required due to different issues with the various products.
The affected products were distributed nationwide, including Puerto Rico, and involved government/military distribution. Foreign distribution included Canada and numerous other countries across multiple continents. The recall number is Z-1994-2019.
Healthcare facilities and users should stop using the affected kits and contact Abbott Laboratories for further instructions regarding the updated documentation.
The recalled product
- Product
- 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 increa
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 2,273
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All IFU's
Distribution
Part of a larger recall action
This product is one of 9 recalled by Abbott Laboratories, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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