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UNICEL DXH 600/800 COULTER CELLULAR ANALYSIS SYSTEM (2016-05-02)
- Starting date:
- May 2, 2016
- Posting date:
- May 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-58406
Affected products
-
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
-
UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
Reason
Beckman Coulter has confirmed an issue where the Red Blood Cell (RBC) aperture baths can contain residue in the sweep flow fittings. This residue may potentially create increased background failures, flagged results and vote outs for RBC and platelet (plt) parameters.
Affected products
A. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Lot or serial number
- AU38544
Model or catalog number
- 629029
- B24802
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES
B. UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
Lot or serial number
- AZ02609
- AZ02611
- AZ02613
- AZ02616
- AZ02618
- AZ02623
Model or catalog number
- B23858
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES