Recall Z-0461-2021— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2020-10-09, terminated 2023-06-09. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001. Reason: Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule.
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-09
- Terminated
- 2023-06-09
- Firm location
- Indianapolis, IN, United States
Product description
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
Reason for recall
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Data sourced from openFDA. This site is unofficial and independent of the FDA.