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Dimension Vista System - MYO Calibrator (2014-11-14)
- Starting date:
- November 14, 2014
- Posting date:
- November 26, 2014
- 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-42625
Recalled Products
Dimension Vista System - MYO Calibrator
Reason
The Dimension Vista Myoglobin Calibrator (MYO CAL) lot 4FD085 may produce a positive shift in MYO QC and patient test results that exceeds their acceptance criteria for this product. Siemens has observed a positive shift up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.
Affected products
Dimension Vista System - MYO Calibrator
Lot or serial number
4FD085
Model or catalog number
KC624
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES