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Coulter Body Fluid Control Level 1
- Starting date:
- November 16, 2016
- 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-61226
Reason
Beckman Coulter has identified an issue with the Coulter Body Fluid Control Level 1 resulting in customers recovering high and/or out of range values for the total nucleated cells (TNC) as compared to the published table of expected results.
Affected products
Coulter Body Fluid Control Level 1
Lot or serial number
- 4511690K
- 4511700K
- 4511710K
- 4511720K
- 4511730K
- 4511740K
- 4511750K
- 4511760K
- 4511770K
Model or catalog number
628030
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES