Company: Ortho Clinical Diagnostics
Date of Enforcement Report: 8/14/2019
Class II
PRODUCT
VITROS 250 Chemistry System, clinical chemistry analyzer
- Recall Number: Z-2174-2019
- Recall Number: Z-2175-2019
VITROS 250AT Chemistry System, clinical chemistry analyzer
- Recall Number: Z-2176-2019
VITROS 350 Chemistry System, clinical chemistry analyzer
- Recall Number: Z-2177-2019
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- Recall Number: Z-2178-2019
VITROS 5600 Integrated System, clinical chemistry analyzer
- Recall Number: Z-2179-2019
- Recall Number: Z-2180-2019
VITROS 4600 Chemistry System, clinical chemistry analyzer
- Recall Number: Z-2181-2019
- Recall Number: Z-2182-2019
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
- Recall Number: Z-2183-2019
- Recall Number: Z-2184-2019
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- Recall Number: Z-2185-2019
REASON
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics on 7/8/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
30
DISTRIBUTION
US Nationwide and International