Recall – Lab management tool alarm not displayed under certain conditions

Company: Roche Diagnostics Corporation
Date of Enforcement Report: 5/29/2019
Class II

PRODUCT

Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use

Recall Number: Z-1368-2019

REASON

Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.

RECALLING FIRM/MANUFACTURER

Roche Diagnostics Corporation on 2/4/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
15 units

DISTRIBUTION

US Nationwide

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Dates:  February 4-6, 2020
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QSS Software Validation
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