Device product
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Z-2739-2015
Product summary
- Event
- Event 71843
- Status
- Terminated
- Classification
- Class II
- Quantity
- 466
- Official record key
device-enforcement:Z-2739-2015
Official wording
Reason: Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
Code information: Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
Distribution pattern: Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
Derived failure modes
-
Unknown
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.