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Health product recall

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