COBAS OMNI LYSIS REAGENT (2019-08-16)

Starting date:

August 16, 2019

Posting date:

September 6, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70901

Last updated: 2019-09-06

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  Reason
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  Affected products

Affected Products

COBAS OMNI LYSIS REAGENT

Reason

Following the information provided by our manufacturer on internal investigation of customer complaints for the cobas omni Lysis reagent  (cat # 06997538190, lot f00997), we would like to inform you of a situation describing increase rate of unexpected reactive results with the cobas West Nile Virus assay  when tested on the cobas 6800-8800 analyzers. The manufacturer advised us of this on 14-Aug-2019.

Affected products