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Health product recall

UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMS (2015-06-29)

Starting date:
June 29, 2015
Posting date:
July 17, 2015
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-54262

Affected Products

A. UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMS 

Reason

Beckman Coulter has confirmed a possible mislabelling of the product name on the front panel of the Sample Transport Module (STM) on some DxH Slidemaker Stainer Coulter Cellular Analysis Systems. Some DxH Slidemaker Stainer Systems are incorrectly labeled as "UniCel DxH 800 Coulter Cellular Analysis System".

Affected products

A. UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMS
 

Lot or serial number
  • AW35122
  • AW35123
  • AW35125
  • AW35126
  • AW45134
  • AW45135
  • AW47148
  • AY04017
  • AY04018
  • AY08027
  • AY10038
  • AY17060
  • AY17064
Model or catalog number

775222

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