Abbott C4 In Vitro Diagnostic Assay Recall for Instruction Manual Updates
Abbott Laboratories is recalling 8,037 C4 in vitro diagnostic assay 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 driven by documentation updates to the Instructions for Use rather than a direct product defect or reported harm, aligning with the rubric for minor labeling or documentation issues.
Plain-English summary
Abbott Laboratories, Inc. is recalling 8,037 kits of the C4 in vitro diagnostic assay. This product is used for the quantitative determination of C4 in human serum or plasma. The recall is being conducted to update the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the Instructions for Use (IFU). The updates are required due to different issues with the various products.
The affected kits were distributed nationwide, including Puerto Rico, and involved government and military distribution. Foreign distribution included Canada and numerous other countries. The recall applies to all Instructions for Use (IFU) associated with these kits.
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
- C4 is an in vitro diagnostic assay for the quantitative determination of C4 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 scattering, measured by reading…
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 8,037
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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