Z-1231-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- December 18, 2019
- Termination Date
- June 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 824 units
Product Description
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Reason for Recall
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.
Distribution Pattern
US Nationwide
Code Information
UDI Number: 00630414595795 Lots: All lots