Z-2180-2019 Class II Terminated
FDA device recall Z-2180-2019 was initiated by Ortho Clinical Diagnostics on July 8, 2019 and is designated Class II. Reason for recall: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System The recall status is terminated (terminated October 19, 2023). Affected quantity: 89.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- July 8, 2019
- Termination Date
- October 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89
Product Description
VITROS 5600 Integrated System, clinical chemistry analyzer
Reason for Recall
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Code Information
product code: 6802915 UDI: 10758750007110 Affected software : Version 3.3.2 or above