This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
UNICEL DXH 800 CELLULAR ANALYSIS SYSTEM (2017-11-06)
- Starting date:
- November 6, 2017
- Posting date:
- November 24, 2017
- 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-65164
Affected products
UNICEL DXH 800 CELLULAR ANALYSIS SYSTEM
Reason
The shield for the single-tube station on the DxH instrument may interfere with sample aspiration in the open vial position. The mechanical interference between the shield and the right (green) position of the single-tube station can cause the tube holder to remain in the down position during aspiration and then spring up, resulting in the dislodging of an open vial. This mechanical interference may result in a biohazardous spill. The left (lavender) position tube holder of the manual station is not impacted by this issue.
Affected products
UNICEL DXH 800 CELLULAR ANALYSIS SYSTEM
Lot or serial number
SERIAL # AS23151
SW VERSION 3.1.1.0
Model or catalog number
629029
B24802
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES