Abbott Hemoglobin A1c Assay Recalled for Falsely Elevated Test Results
Abbott Laboratories is recalling hemoglobin A1c test reagents used with ARCHITECT and Alinity c analyzers. The assay may produce falsely elevated A1c results, potentially affecting diabetes patient management.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential to produce inaccurate test results critical for diabetes management. No illnesses or injuries reported. The theoretical hazard to patient care through incorrect A1c measurement justifies High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Laboratories is recalling hemoglobin A1c test reagent kits (REF: 4P52-20) used with ARCHITECT and Alinity c hemoglobin A1c analyzers. Approximately 103,316 units have been distributed across the United States and internationally.
The recall was initiated because the reagent has the potential to produce falsely elevated hemoglobin A1c results. Hemoglobin A1c testing is critical for diagnosing and monitoring diabetes. Falsely elevated results could lead to incorrect treatment decisions.
The affected reagent kits have been distributed across the United States and to numerous countries worldwide. Specific lot numbers affected include 59588UQ04, 59868UQ05, 59900UQ06, 60138UQ07, 60237UQ08, 60535UQ08, 60698UQ09, 60880UQ10, 61066UQ11, 61246UQ01, and 61250UQ01.
The recalled product
- Product
- REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
- Manufacturer
- Abbott Laboratories
- Affected units
- 103,316
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 (11)
- UDI/DI: 00380740102746/ Lots: 59588UQ04
- 59868UQ05
- 59900UQ06
- 60138UQ07
- 60237UQ08
- 60535UQ08
- 60698UQ09
- 60880UQ10
- 61066UQ11
- 61246UQ01
- 61250UQ01
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Laboratories 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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