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DIMENSION VISTA SYSTEM - PHENYTOIN ASSAY (2015-04-15)
- Starting date:
- April 15, 2015
- Posting date:
- May 6, 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-53261
Recalled Products
A.DIMENSION VISTA SYSTEM - PHENYTOIN ASSAY
Reason
Siemens healthcare diagnostics has confirmed an increase in the rate of abnormal assay errors (E143: outside absolute results monitoring limits) with the Dimension Vista Phenytoin (PTN) flex reagent cartridge lots 14163AB and 14181AC. The errors can occur on calibration, QC and/or patient samples.
Affected products
A.DIMENSION VISTA SYSTEM - PHENYTOIN ASSAY
Lot or serial number
14163AB
14181AC
Model or catalog number
K4064
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 Gbc Drive
Mailstop 514
Delaware
UNITED STATES