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COULTER 5C Cell Control, Abnormal II (2014-12-01)
- Starting date:
- December 1, 2014
- Posting date:
- December 11, 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-42855
Recalled Products
COULTER 5C Cell Control, Abnormal II
Reason
Beckman Coulter has confirmed a low and/or out of expected Basophil percent (BA%) recovery range for the 5C abnormal ii cell control lots referenced. This issue only affects the 5C Abnormal II cell Control Basophil percent (BA%) recovery. The laboratory may fail quality control for the BA% at the concentrations in the 5C Abnormal II Cell Control only.
Affected products
COULTER 5C Cell Control, Abnormal II
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
624506
7547001
7547011
7547116
7547124
7547199
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES