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ADVIA CHEMISTRY SYSTEMS (2015-09-23)
- Starting date:
- September 23, 2015
- Posting date:
- October 14, 2015
- 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-55356
Affected Products
- ADVIA CHEMISTRY SYSTEM -ALKALINE PHOSPHATASE (ALPAMP)ASSAY
- ADVIA 1200 CHEMISTRY SYSTEM -ALKALINE PHOSPHATASE (ALPAMP)ASSAY
Reason
Siemens Healthcare Diagnostics has confirmed that the Alkaline Phosphatase Reagent Kit lots listed on the report used on the ADVIA 1200, 1650, 1800, 2400 and XPT Chemistry Systems demonstrate an increased incidence of absorbance flags (u,U) and //// errors. Absorbance flags u and U indicate abnormal high absorbance exceeding either the blank or sample limit. Absorbance flag //// indicates a calculation error and no result is generated by the system.
Affected products
A. ADVIA CHEMISTRY SYSTEM -ALKALINE PHOSPHATASE (ALPAMP)ASSAY
Lot or serial number
327460
Model or catalog number
3035814
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. ADVIA 1200 CHEMISTRY SYSTEM -ALKALINE PHOSPHATASE (ALPAMP)ASSAY
Lot or serial number
327460
Model or catalog number
03035814
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES