Cobas 6800 & 8800 (2019-10-08)

Starting date:

October 8, 2019

Posting date:

November 8, 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-71543

Last updated: 2019-11-08

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  Reason
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  Affected products

Affected Products

A. Cobas 6800

B. Cobas 8800

Reason

Following the information provided by our manufacturer on internal investigation of customer complaints, we would like to inform you of a situation where the manufacturer has requested to disable the specimen diluent container minimum level sensor of the cobas 6800-8800 analyzers (cat # 05524245001, 05412722001) since it was detecting the diluent container as empty despite being full. The manufacturer advised us of this on 30-Sep-2019.

Affected products