Recall Z-1158-2020— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2020-01-07, terminated 2020-10-15. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.. Reason: Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-07
- Terminated
- 2020-10-15
- Firm location
- Indianapolis, IN, United States
Product description
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Reason for recall
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
Data sourced from openFDA. This site is unofficial and independent of the FDA.