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