Health product recall

UniCel DxH 600, 800, and 900 Coulter Cellular Analysis System (2018-08-01)

Starting date:
August 1, 2018
Posting date:
June 4, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67414



Last updated: 2019-06-04

Affected Products

  1. UniCel DxH 800 Coulter Cellular Analysis System
  2. UniCel DxH 600 Coulter Cellular Analysis System
  3. UniCel DxH 900 Coulter Cellular Analysis System

Reason

Beckman Coulter has confirmed complaints of sporadic erroneously elevated platelet results without flags or system messages. Other parameters are not affected by this issue. The platelet parameter may be erroneously elevated without flags or system messages. Erroneously elevated results could be reported out of the laboratory.

Affected products

A. UniCel DxH 800 Coulter Cellular Analysis System

Lot or serial number

Software 3.2.0 and below

Model or catalog number
  • 629029
  • B24465
  • B24802
Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES


B. UniCel DxH 600 Coulter Cellular Analysis System

Lot or serial number

Software 1.3.0 and below

Model or catalog number

B23858

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES


C. UniCel DxH 900 Coulter Cellular Analysis System

Lot or serial number

All lots.

Model or catalog number

C11478

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES