Abbott Haptoglobin Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 5,694 Haptoglobin Assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
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 hazard or reported illness, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Abbott Laboratories, Inc. is recalling 5,694 kits of the Haptoglobin Assay (HP assay). This product is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. 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 kits were distributed nationwide, including Puerto Rico, and included government/military distribution. Foreign distribution was made to numerous countries, including Canada, Australia, China, India, and the United Kingdom. The recall applies to all Instructions for Use (IFU) associated with these kits.
Consumers and healthcare facilities should stop using the affected kits and contact Abbott Laboratories for further instructions regarding the updated documentation.
The recalled product
- Product
- The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming i
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 5,694
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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