Alinity I Homocysteine 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 I Homocysteine Reagent Kit |
11486UP00, 11466UP00, 11453UP00, 11485UP00, 11406UP00 |
09P2820 |
Issue
The purpose of this notification is to inform you of a product correction for the Alinity I Homocysteine Reagent Kits listed in the letter. Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control results. If your laboratory has established statistically‐based control limits at each clinically relevant control level, your controls will detect the shift out of range. If quality control results do not meet the acceptance criteria defined by your laboratory, sample results may be suspect and should not be reported.
Recall start date: Mar 25, 2022
Additional information
Details
Abbott Gmbh
Max-Planck-Ring 2, Wiesbaden
Germany, 65205
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