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ADVIA CENTAUR XPT INSTRUMENT (2016-05-27)
- Starting date:
- May 27, 2016
- Posting date:
- June 13, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-58854
Affected products
A. ADVIA CENTAUR XPT INSTRUMENT
Reason
Siemens Healthcare Diagnostics has identified multiple issues with ADVIA Centaur XPT system software versions V1.0.1 Bbundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). These issues may affect the results generated by the system and are described below:
- Sample tip error
- Daily maintenance
- Result reporting for high/low linearity samples
- Auto-repeat conditions
- Barcode misreads in rack id mode
- Low probe wash
- Las communication
- System status unknown
Affected products
A. ADVIA CENTAUR XPT INSTRUMENT
Lot or serial number
All lots
Model or catalog number
10711433
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES