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Health product recall

Cobas Chemistry Analyzers (2017-07-20)

Starting date:
July 20, 2017
Posting date:
August 15, 2017
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-64222

Affected Products

A. Cobas 6000 - C501 Chemistry Analyzer
B. Cobas 8000-C502 Chemistry Analyzer

Reason

During regular maintenance of the Ultrasonic Mixer Cover (USM Cover 3) of the Cobas C501 and Cobas C502, a potential injury could occur if the customer does not notice the clearly visible sharp edge while removing the screws.

Affected products

A. Cobas 6000 - C501 Chemistry Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

04745914001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY

B. Cobas 8000-C502 Chemistry Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

05964067001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY