Recall Z-1456-2022— Abbott Laboratories
Class II · Ongoing
Class II FDA medical device recall by Abbott Laboratories, initiated 2022-06-09. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-09
- Firm location
- Irving, TX, United States
Product description
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
Reason for recall
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Data sourced from openFDA. This site is unofficial and independent of the FDA.