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Health product recall

Unicel DXH Slidemaker Stainer System (2014-02-06)

Starting date:
February 6, 2014
Posting date:
March 21, 2014
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-38485

Recalled Products

Unicel DXH Slidemaker Stainer System

Reason

If the "ordering physician" option is selected in the system manager label configuration screen, the Unicel DXH slide maker stainer coulter cellular analysis system will print the name of the primary physician instead of the ordering physician on the slide label. The ordering physician's name correctly transmits to the laboratory information system. the primary identifier, the date/time and other demographic information will appear as selected on the slide label. Slide making and staining quality are not affected.

Affected products

Unicel DXH Slidemaker Stainer System

Lot or serial number

775222

Model or catalog number

More than 10 numbers, contact manufacturer 

Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES