Abbott C3 In Vitro Diagnostic Assay Recall for Instruction Manual Update
Abbott Laboratories is recalling 8,132 C3 in vitro diagnostic 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 action is for an update to the Instructions for Use (IFU) rather than a physical defect or contamination. This aligns with the rubric for minor labeling/documentation issues or voluntary precautionary recalls where no specific injury or illness is reported.
Plain-English summary
Abbott Laboratories, Inc. is recalling 8,132 kits of the C3 in vitro diagnostic assay. This product is used for the quantitative determination of C3 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 update is required due to different issues with the various products. The affected kits were distributed nationwide, including Puerto Rico, as well as to government and military entities. Foreign distribution included numerous countries across multiple continents.
Healthcare facilities and laboratories should stop using the affected kits and contact Abbott Laboratories for instructions on how to obtain the updated Instructions for Use. Consumers should not use these products for home testing, as they are intended for professional in vitro diagnostic use.
The recalled product
- Product
- C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increa
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 8,132
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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