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UniCel DxH 600 and 800 Coulter Cellular Analysis Systems (2016-12-19)
- Starting date:
- December 19, 2016
- Posting date:
- January 12, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61746
Affected Products
A. UniCel DxH 800 Coulter Cellular Analysis System
B. UniCel DxH 600 Coulter Cellular Analysis System
Reason
Beckman Coulter has determined that additional clarification for the blast suspect messages is necessary. In rare situations, the UNICEL DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.
Affected products
A. UniCel DxH 800 Coulter Cellular Analysis System
Lot or serial number
All lots
Model or catalog number
629029
B24802
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES
B. UniCel DxH 600 Coulter Cellular Analysis System
Lot or serial number
All lots
Model or catalog number
B23858
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES