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
Reported: November 25, 2020 Initiated: October 9, 2020 #Z-0461-2021
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
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 40 licenses
- Distribution
- Nationwide
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 40 licenses.
Why was this product recalled? ▼
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0461-2021.
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