Abbott Alinity c Hemoglobin Reagent Kit may produce falsely elevated test results
Abbott Laboratories is recalling the Alinity c Hemoglobin Reagent Kit because the ARCHITECT and Alinity c assays can generate falsely elevated Hemoglobin A1c results.
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: FDA Class II medical device recall without reported illnesses, injuries, or hospitalizations. The hazard is a potential for falsely elevated test results, which presents a risk of incorrect clinical decisions. Per the rubric, this qualifies as a risk-of-harm scenario without reported injury, scoring at 3 (High).
Plain-English summary
Abbott Laboratories is recalling approximately 7,391 units of the Alinity c Hemoglobin Reagent Kit (REF: 08P4320). The affected product has been distributed throughout the United States and internationally to over 100 countries.
The ARCHITECT and Alinity c Hemoglobin A1c assays are capable of generating falsely elevated hemoglobin A1c test results when using affected reagent lots. Falsely elevated results may lead to incorrect clinical decisions regarding patient diagnosis and treatment.
The affected product is identified by UDI/DI 00380740135591 and the following lot numbers: 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, and 61658UQ01.
The recalled product
- Product
- REF: 08P4320, 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
- falsely-elevated-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 (7)
- UDI/DI: 00380740135591/ Lots: 59561UQ04
- 59779UQ05
- 60229UQ07
- 60540UQ09
- 61011UQ10
- 61349UQ01
- 61658UQ01
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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