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Advia Chemistry Systems (2013-11-11)
- Starting date:
- November 11, 2013
- Posting date:
- December 4, 2013
- 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-36997
Recalled products
- Advia Chemistry System - Advia 1650 Analyzer
- Advia 1200 Chemistry System - Instrument
- Advia Chemistry System - Advia 1800 Analyzer
- Advia Chemistry System - Advia 2400 Analyzer
Reason
Siemens confirms that three issues were identified where the system may pass calibration and QC, when it should not. These include auto-calibration with flagged system related errors, auto-calibration with a lot change and reagent pack switching mid-calibration or mid-QC. Users are being advised when any of the three situations occur, to perform the calibration or QC again.
Affected products
A. Advia Chemistry System - Advia 1650 Analyzer
Lot or serial number
- CA175542364
Model or catalog number
- 06363413
- 073-B002-01
- 10309735
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. Advia 1200 Chemistry System - Instrument
Lot or serial number
- CA12240082
- CA12250023
- CA12250055
- CA12250088
- CA12260019
- CA12260020
- CA12260038
- CA12270027
Model or catalog number
- 02475632
- 094-A002-01
- 10309735
- M094-A002-01
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
C. Advia Chemistry System - Advia 1800 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 01412173
- 073-A021-01
- 10315183
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
D. Advia Chemistry System - Advia 2400 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 01714935
- 073-A011-02
- 10315769
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES