Recall Z-2178-2019— Ortho Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho Clinical Diagnostics, initiated 2019-07-08, terminated 2023-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer. Reason: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System.
- Recalling firm
- Ortho Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-08
- Terminated
- 2023-10-19
- Firm location
- Rochester, NY, United States
Product description
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Reason for recall
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Data sourced from openFDA. This site is unofficial and independent of the FDA.