Abbott Immunoglobulin M Diagnostic Assay Recalled for Instruction Manual Errors
Abbott Laboratories is recalling 9,586 Immunoglobulin M diagnostic kits because the instructions for use contained errors in the reagents 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 limited to documentation errors in the Instructions for Use (IFU) without reporting of patient harm, illness, or injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Abbott Laboratories, Inc. is recalling 9,586 kits of the Immunoglobulin M in vitro diagnostic assay. This product is used to quantitatively determine immunoglobulin M levels in human serum or plasma. The recall was initiated because an update to the Instructions for Use (IFU) was required to address different issues found in the Reagents and Specimen Collection and Handling/Preparation for Analysis sections.
The affected kits were distributed nationwide, including Puerto Rico, as well as to government and military entities. Foreign distribution included Canada and numerous other countries across multiple continents. 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 instructions on how to return or replace the product. Consumers who have purchased this product should contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M 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 scat
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 9,586
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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