The Recall Desk
HighFDA (Devices)·Z-0461-2021·Announced 2020-11-25

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.

What this means for you

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.
Category
Medical Device — Laboratory Software
Hazard
Affected units
40

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Roche Diagnostics Operations, Inc.

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