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Dimension vista System-Chem calibrators
- Starting date:
- September 20, 2016
- 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-60454
Affected Products
Reason
Siemens Healthcare Diagnostics has confirmed that DIMENSION VISTA CHEM 1 CAL Lots 5GM081 and 5GM082 may produce depressed results with current lots of calcium reagent. Although the affected CHEM 1 CAL lots are expired, the calcium calibration interval is 90 days, therefore it is possible that calibrations using the calibrator lots are active.
Affected products
Dimension vista System-Chem calibrators
Lot or serial number
- 5GM081
- 5GM082
Model or catalog number
- K110B
- KC110
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES