Device product
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
Z-1004-2015
Product summary
- Event
- Event 69727
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12 units
- Official record key
device-enforcement:Z-1004-2015
Official wording
Reason: Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
Code information: System Product Code: 1) 6802445, 2) 6802413
Distribution pattern: Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain.
Derived failure modes
-
Unknown
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.