Cobas Infinity Central Lab
Brand(s)
Last updated
Summary
Product
Cobas Infinity Central Lab
Issue
Medical devices - Performance
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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