Abbott Transferrin Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 22,359 Transferrin in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 to the Instructions for Use rather than a physical defect or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Abbott Laboratories, Inc. is recalling 22,359 kits of the Transferrin in vitro diagnostic assay. This product is used for the quantitative determination of transferrin 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 kits were distributed nationwide, including Puerto Rico, and were also distributed to government and military entities. Foreign distribution included Canada and numerous other countries. The recall applies to all Instructions for Use (IFU) associated with these kits.
Healthcare facilities and laboratories should stop using the affected kits and contact Abbott Laboratories for further instructions regarding the updated documentation.
The recalled product
- Product
- Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light…
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 22,359
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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