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DIMENSION VISTA SYSTEM - CALCIUM ASSAY (2016-08-11)
- Starting date:
- August 11, 2016
- Posting date:
- August 26, 2016
- 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-59978
Affected Products
DIMENSION VISTA SYSTEM - CALCIUM ASSAY
Reason
Manufacturer has confirmed that Dimension Vista Calcium (CA) flex reagent cartridge lot 16060bb may produce erroneously low results from specific well sets. This issue occurs infrequently, affecting less than 1 per 350 wells (< 0.3%). If calibration is performed using an unaffected well set and samples are subsequently run using an affected well set, Ca results may be falsely depressed up to -2.9 mg/dl [-0.72 mmol/l]. If QC is run using an affected well set, QC may detect the issue.
Affected products
DIMENSION VISTA SYSTEM - CALCIUM ASSAY
Lot or serial number
16060BB
Model or catalog number
K1023
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark, Delaware
19714-6101
UNITED STATES