Health product recall

Cobas Infinity Central Lab

Last updated

Summary

Product
Cobas Infinity Central Lab
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Cobas Infinity Central Lab

software versions 3.02.02 to 3.02.15
software versions 3.03.05 to 3.03.15

09180443001
07154003001

Issue

Under two very specific scenarios with Cobas e Flow configurations, the test may generate false positive or false negative results in the Cobas Infinity Central Lab. In Canada, none of their customers configured according to the impacted scenarios, therefore they are not impacted by the issue but are informed as a preventive action. 

Recall start date: April 11, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Roche Diagnostics GmbH

Sandhoferstrasse 116, Mannheim, Germany, 68305

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73538

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