Device product
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Z-1231-2020
Product summary
- Event
- Event 84612
- Status
- Terminated
- Classification
- Class II
- Quantity
- 824 units
- Official record key
device-enforcement:Z-1231-2020
Official wording
Reason: There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
Code information: UDI Number: 00630414595795 Lots: All lots
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.