Device product
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Z-2185-2019
Product summary
- Event
- Event 83322
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2185-2019
Official wording
Reason: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Code information: product code:6844508 UDI: 10758750032105 Affected Assay Data Disk (ADD) DRV No: DRV 6032 or above
Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Derived failure modes
-
Device software or design
Software Anomaly