Alinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results
Abbott Laboratories is recalling Alinity c Hemoglobin Reagent Kits (lots 59801UQ04 and 60763UQ09) due to a potential for falsely elevated hemoglobin A1c test results when used with ARCHITECT and Alinity c analyzers.
What this means for you
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: This FDA Class II recall involves a functional defect in a medical diagnostic device that could lead to patient harm through inaccurate test results. However, no illnesses or injuries have been reported, and the hazard is characterized as potential rather than confirmed, capping the severity at High (3) per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Abbott Laboratories is recalling specific lots of the Alinity c Hemoglobin Reagent Kit (REF: 08P4377), an in vitro diagnostic kit used with ARCHITECT and Alinity c hemoglobin analyzers. The affected lots are 59801UQ04 and 60763UQ09 (64 units total).
The FDA classified this as a Class II recall due to a potential for falsely elevated hemoglobin A1c and hemoglobin %A1c results when using the affected reagent kits. These inaccurate test results could lead to incorrect clinical decisions if not identified and corrected.
The affected products were distributed to clinical laboratories and healthcare facilities across all U.S. states and territories, as well as internationally to numerous countries.
Laboratories currently using the affected lots should immediately cease use and contact Abbott Laboratories for instructions on replacement. Healthcare providers should verify the accuracy of any hemoglobin A1c test results obtained using the recalled reagent kits.
The recalled product
- Product
- REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
- Manufacturer
- Abbott Laboratories
- Hazard
- inaccurate-diagnostics
- false-test-results
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)
- UDI/DI: 00380740174989/ Lots: 59801UQ04 and 60763UQ09
Distribution
Distributed in 43 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
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