Roche Recalls cobas infinity Software Due to Incorrect Validation
Roche Diagnostics is recalling 40 cobas infinity central lab licenses because an erroneous QC status may cause incorrect validation of results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect validation of medical results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 40 licenses of the cobas infinity central lab/cobas infinity core license software. The software is intended for the configuration and connectivity management of instruments and software systems.
The recall is due to a potential issue where an erroneous QC status, when using the Status Expiration Control Rule, may lead to the incorrect validation of results. This defect affects software versions from cobas infinity version 3.00.00 onwards.
The affected units are identified by specific serial numbers listed in the agency's recall record. The products were distributed nationwide. Users of the affected software should contact Roche Diagnostics for further instructions on how to resolve the issue.
The recalled product
- 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
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 40
Distribution
Distributed nationwide across the United States.
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