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UNICEL DXH COULTER ANALYSIS SYSTEM (2015-12-01)
- Starting date:
- December 1, 2015
- Posting date:
- January 7, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56518
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
Beckman Coulter determined that the affected software for the DXH systems allows the creation of multiple orders with the same specimen identification (ID) but different patient identification when manually editing pending orders at the system manager. The issue does not occur for edits of released results or for test orders requested through host transmission. The issue creates the potential for sample misidentification and potential of releasing erroneous results.
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.
Brea
92821
California
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.
Brea
92821
California
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.
Brea
92821
California
UNITED STATES