Device product
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Z-1933-2019
Product summary
- Event
- Event 82784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5020 units
- Official record key
device-enforcement:Z-1933-2019
Official wording
Reason: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Code information: All lots
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.