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Dimension Vista System - Chem Calibrators (2014-08-08)
- Starting date:
- August 8, 2014
- Posting date:
- August 22, 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-41127
Recalled Products Produits retirés de marché
Dimension Vista System - Chem Calibrators
Reason
Siemens Healthcare Diagnostics has received complaints for low recovery for magnesium (Mg) quality control (QC) and patient samples following calibration of Mg with Dimension Vista Chem 1 Cal lot 3GM081. Investigation by Siemens confirms that QC and patient samples show low recovery of Mg by 0.25 mg/dl [0.10 mmol/l] across the assay range following calibration with 3GM081.
Affected products
Dimension Vista System - Chem Calibrators
Lot or serial number
3GM081
Model or catalog number
KC110
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES