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Advia Chemistry Enzyme 2 Calibrator
- Starting date:
- July 18, 2017
- Posting date:
- August 15, 2017
- 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-64212
Reason
Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for aspartate aminotransferase (AST) and aspartate aminotransferase concentrated (AST_C) assays following calibration with Advia Chemistry Enzyme 2 Calibrator Lots 6JD079 and 6MD042. Only aspartate aminotransferase (AST) and aspartate aminotransferase concentrated (AST_C) assays are affected. All other assays (ALT, ALT_C, ALTP5P, ALTP_C, ASTP5P and ASTP_C) using the Advia Chemistry Enzyme 2 Calibrator are not impacted.
Affected products
Advia Chemistry Enzyme 2 Calibrator
Lot or serial number
6JD079
6MD042
Model or catalog number
10916058
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES