Abbott Lipase Reagent Recalled for Incorrect Package Insert Parameters
Abbott Laboratories is recalling Lipase Reagent 7D80 because package inserts contain incorrect SmartWash parameters for Triglyceride.
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 defect is a documentation error (incorrect package insert parameters) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Abbott Laboratories, Inc. is recalling 11,916 units of Lipase Reagent, 7D80. This product is used to measure lipase in human serum on the Architect system. The recall is due to package inserts that contain incorrect SmartWash parameters for Triglyceride.
The affected lots are 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11. The products were distributed nationwide in the United States and in numerous countries worldwide, including Canada, the United Kingdom, and Australia.
This is an FDA Class II recall. The source text does not report any illnesses or injuries associated with this defect. Users should contact Abbott Laboratories for instructions on how to proceed.
The recalled product
- Product
- Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 11,916
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 (9)
- lots 43827UQ12
- 43819UQ03
- 44449UQ05
- 44127UQ06
- 44334UQ07
- 43994UQ07
- 44596UQ08
- 44775UQ09
- and 44930UQ11.
Distribution
Distributed nationwide across the United States.
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