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Health product recall

Unicel DXH Slidemaker Stainer

Starting date:
October 1, 2012
Posting date:
October 29, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15138

Recalled Products:

Unicel DXH Slidemaker Stainer

Reason

The DXH SMS systems generates an incorrect "invalid delimiters" message, when the host transmits the minimal header record. When this issue occurs, the DXH SMS does not store the test order in the worklist which results in the specimen being processed by a default order or skipped (when no default order is selected at the system manager).

Affected products

Unicel DXH Slidemaker Stainer

Lot or serial number

Software Version 1.5.1.0

Model or catalog number

775222

Companies
Manufacturer
Beckman Coulter Inc.