Alinity and Architect A1C Reagent Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Alinity C Hemoglobin A1C Reagent Kit |
61658UQ01 |
08P4320 |
Architect Hemoglobin A1C Reagent |
60535UQ08 |
4P52-20 |
Issue
This recall is to inform of a potential for falsely elevated hemoglobin %A1C and hemoglobin A1C patient results to be generated using the architect hemoglobin A1C assay when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low total hemoglobin values. to address this issue, a revision to the total hemoglobin low linearity value for the architect hemoglobin a1c whole blood and hemolysate applications has been implemented.
Recall start date: June 15, 2022
Additional information
Details
Abbott GmbH
Max-Planck-Ring 2, Wiesbaden, Germany, 65205
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