Recall Z-2184-2019— Ortho Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho Clinical Diagnostics, initiated 2019-07-08, terminated 2023-10-19. It names one FDA 510(k) clearance: K063144. Product: VITROS 5,1 FS Chemistry System, 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VITROS 5,1 FS Chemistry System, 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.