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UniCel DxH Analysis Systems (2016-04-05)
- Starting date:
- April 5, 2016
- Posting date:
- April 22, 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-58032
Affected products
A. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
B. UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
C. UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
Reason
The DxH 800, DxH 600, and DxH Slidemaker Stainer may fail to notify the user of warnings or error conditions for low or depleted reagent conditions, daily checks failures, LIS disconnection, and printer failures at:
- the alert status icon(s) on the system manager
- the audible alarm at the system manager
- the instrument beacon on the specimen processing module or Slidemaker Stainer
the failure may occur when the system manager application is restarted or powered off/on.
Affected products
A. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Lot or serial number
All lots
Model or catalog number
629029
B24802
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES
B. UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
Lot or serial number
All lots
Model or catalog number
775222
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES
C. UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
Lot or serial number
All lots
Model or catalog number
B23858
Companies
- Manufacturer
-
Beckman Coulter
Inc.
250 S. Kraemer Blvd.
92821
UNITED STATES