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Beckman Coulter Cell Preparation System FP1000 (2013-11-25)
- Starting date:
- November 25, 2013
- Posting date:
- January 13, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices, Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals, General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37465
Recalled products
- Beckman Coulter Cell Preparation System FP1000
Reason
Beckman Coulter has confirmed that the silkscreen label on the left leg/panel of the FP1000 cell preparation system at a customer site incorrectly identifies the fuse rating associated with the two fuses located on that panel. The rating is shown as 100A instead of 6.0A on the label.
Affected products
A. Beckman Coulter Cell Preparation System FP1000
Lot or serial number
Serial Numbers:
- AH20011
- AJ44027
Model or catalog number
- 624922
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES