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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
- 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