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
- UniCel DxH 800 Coulter Cellular Analysis System
- UniCel DxH 600 Coulter Cellular Analysis System
- 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