Device product
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
Z-1931-2020
Product summary
- Event
- Event 85363
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1931-2020
Official wording
Reason: The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Code information: CKMB Slides that expire after July 20, 2018 and within current expiry.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.