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Dimension Vista System - Enzyme Calibrator (2014-01-20)
- Starting date:
- January 20, 2014
- Posting date:
- February 11, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37925
Recalled products
- Dimension Vista System - Enzyme Calibrator
Reason
There have been reports of quality control (QC) shifts with pseudocholinesterase (PCHE) and imprecision during PCHE calibration with Dimension Vista enzyme 1 calibrator (ENZ 1 cal) lots 3FD034 and 3HD012. Investigation by Siemens confirms a loss of PCHE activity in the affected lots of enzyme 1 calibrator, causing an elevation of qc by as much as 80% and in some instances, imprecision of replicates during calibration.
Affected products
A. Dimension Vista System - Enzyme Calibrator
Lot or serial number
- 3FD034
- 3HD012
Model or catalog number
- KC310
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES