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Coulter Body Fluid Control (2014-01-20)
- Starting date:
- January 20, 2014
- Posting date:
- March 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38325
Recalled Products
Coulter Body Fluid Control
Reason
Beckman Coulter has received customer complaints reporting that certain lots of Coulter body fluid control level 2 receovered low and / or out-of-range for the red blood cell (RBC) parameter on the Unicel DXH Coulter Cellular Analysis systems. Body fluid control levels 1 and 3 do not exhibit this issue. Body fluid control values for total nucleated cell (TNC) for all levels are not affected.
Affected products
Coulter Body Fluid Control
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
628030
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES