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Health product recall

PSM Software (2014-08-13)

Starting date:
August 13, 2014
Posting date:
September 24, 2014
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-41487

Recalled products

  1. PSM Software 

Reason

Test results (non-validated) may be released by the PSM to the Laboratory Information System (LIS). This issue occurs when the laboratory information system sends incorrect collection date and time information or format to PSM.

Affected products

A. PSM Software

Lot or serial number

More than 10 numbers, contact manufacturer.   

Model or catalog number
  • 04944607001
Companies
Manufacturer
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY