Z-0922-2020 Class II Terminated
FDA device recall Z-0922-2020 was initiated by Roche Diagnostics Operations, Inc. on October 8, 2019 and is designated Class II. Reason for recall: Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping The recall status is terminated (terminated October 15, 2020). Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- October 8, 2019
- Termination Date
- October 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
Reason for Recall
Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
Distribution Pattern
US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN
Code Information
Cobas infinity software version 2.4.1 through 2.5.4