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Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis System
- Starting date:
- June 19, 2017
- Posting date:
- July 17, 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-63970
Reason
Beckman Coulter has determined that a fitting installed in a select population of Slidemaker Stainer (SMS) units may not completely seal after being installed.
Not all fittings installed may be affected. For those affected, one may observe a slow dripping leak of the staining reagents (methanol, alcohol and buffers) into the spill tray below designed for this purpose.
Affected products
Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis System
Lot or serial number
SW VERSION 3.2
Model or catalog number
775222
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
UNITED STATES