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Coulter DXH Diluent (2014-08-25)
- Starting date:
- August 25, 2014
- Posting date:
- September 25, 2014
- 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-41509
Recalled products
- Coulter DXH Diluent
Reason
Beckman coulter has determined that the use of affected lots of the coulter DXH diluent may be associated with elevated platelet (PLT) background counts between 3-7 x 10^3 cells/ul, that will result in failed daily checks on the Unicel DXH 800 and DXH 600 Coulter Cellular Analysis Systems.
Affected products
A. Coulter DXH Diluent
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 628017
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES