Cobas Infinity Central Lab (2021-01-21)

Starting date:

January 21, 2021

Posting date:

February 5, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74909

Last updated:
2021-02-05

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  Reason
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  Affected products

Affected Products 

Cobas Infinity Central Lab

Reason

The manufacturer confirmed an issue with the cobas infinity using software version 3.00.00 And onwards. Under certain circumstances, the SI_WSI result status is removed from the SI sensitive test when alphanumeric results are received

Affected products