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Advia Chemistry Systems (2014-01-23)
- Starting date:
- January 23, 2014
- Posting date:
- March 19, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38305
Recalled Products
Advia Chemistry Systems
Reason
Siemens Healthcare Diagnostics is conducting a recall for Advia 1800 and Advia 2400 ISE firmware v2.23. Advia Chemistry Chloride Electrodes may fail prematurely during calibration due to a chloride bias parameter error. The operator will receive an ng flag which requires immediate action to be taken on the calibration samples.
Affected products
A. Advia Chemistry System - Advia 1800 Analyzer Class 2
Lot or serial number
All lots
Model or catalog number
01412173
073-A021-01
10315183
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. Advia Chemistry System - Advia 2400 Analyzer Class 2
Lot or serial number
All lots
Model or catalog number
01714935
073-A011-02
10315769
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES