Abbott Immunoglobulin G Diagnostic Assay Recall for IFU Updates
Abbott Laboratories is recalling 11,063 Immunoglobulin G in vitro diagnostic kits to update instructions for use 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 for an update to the Instructions for Use (IFU) regarding reagents and specimen handling, which constitutes a labeling/documentation issue without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Abbott Laboratories, Inc. is recalling 11,063 kits of the Immunoglobulin G in vitro diagnostic assay. This product is used for the quantitative determination of immunoglobulin G in human serum or plasma. The recall is being conducted to update the Instructions for Use (IFU) specifically within the Reagents and Specimen Collection and Handling/Preparation for Analysis sections.
The update is required due to different issues identified with the various products. The recall number is Z-1989-2019. The agency classification for this recall is Class II.
Distribution was nationwide, including Puerto Rico, and included government and military distribution. Foreign distribution was made to numerous countries including Canada, Australia, China, India, and the United Kingdom. Users should refer to the updated instructions for use provided by the manufacturer.
The recalled product
- Product
- Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G 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
- 11,063
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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