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Health product recall

Immage Immunochemistry System (2013-08-19)

Starting date:
August 19, 2013
Posting date:
January 6, 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-37249

Recalled products

  1. Immage Immunochemistry System
  2. Immage 800 Immunochemistry System
  3. Reconditioned Immage

Reason

Beckman Coulter has verified that three fluid filters installed in the following locations on Immage or Immage 800 systems may prematurely fail (Clog): Reagent probe wash station, Sample probe wash station and Cuvette wash station.

Affected products

A. Immage Immunochemistry System

Lot or serial number

All lots

Model or catalog number
  • 470000
  • 470010
  • 470664
Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES

B. Immage 800 Immunochemistry System

Lot or serial number

All lots

Model or catalog number
  • A15445
  • A15501
Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES

C. Reconditioned Immage

Lot or serial number

All lots

Model or catalog number
  • 463804
  • 463805
  • 463812
Companies
Manufacturer
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES