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UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (2015-06-23
- Starting date:
- June 23, 2015
- Posting date:
- July 17, 2015
- 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-54226
Affected Products
A. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Reason
Beckman Coulter has confirmed low recovery values for Reticulocytes may be generated from the UniCel DxH 800 Coulter Cellular Analysis System due to intermittent high electrical noise on the Upper Median Angle Light Scatter (UMAL) produced by the volume, conductivity, scatter and multiple angle (VCSN) preamp board assembly part number (PN) b48187. The electrical noise produced by the VCSN preamp board assembly is greater than the instrument specification of 3.000 millivolt root mean square (MV RMS).
Affected products
A. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Lot or serial number
S/N: AY19258
S/N: AY19259
Model or catalog number
B24802
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
California
UNITED STATES