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DIMENSION VISTA SYSTEM - LOCI 8 CALIBRATOR (2017-11-07)
- Starting date:
- November 7, 2017
- Posting date:
- November 22, 2017
- 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-65216
Affected products
DIMENSION VISTA SYSTEM - LOCI 8 CALIBRATOR
Reason
Siemens Healthcare Diagnostics has confirmed an increase in the number of failed calibration events or negative bias with quality control (QC) and patient samples when using Dimension Vista Loci 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.
Affected products
DIMENSION VISTA SYSTEM - LOCI 8 CALIBRATOR
Lot or serial number
7CD076
Model or catalog number
KC646
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES