This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Coulter HMX Hematology Analyzer and Coulter LH 500 Series Analyzer

Starting date:
October 10, 2011
Posting date:
January 9, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Hospitals, Healthcare Professionals, General Public
Identification number:
RA-15106

Recalled products

A. Coulter HMX Hematology Analyzer with AutoLoader

B. Coulter LH 500 Series Analyzer

Reason

There is a potential for counterfeit integrated circuit chips on four different analyzer circuit boards of the LH500 and HMX devices.

Affected products

A. Coulter HMX Hematology Analyzer with AutoLoader
Lot or serial number

AC34080

AF04036

AF24282

AF51694

13121

Model or catalog number

6605526

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES


B. Coulter LH 500 Series Analyzer
Lot or serial number

> 10 numbers; contact manufacturer

Model or catalog number

178833

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES