Device product
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System.
Z-2720-2014
Product summary
- Event
- Event 69063
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9769 Total (6000 US)
- Official record key
device-enforcement:Z-2720-2014
Official wording
Reason: Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.
Code information: lot 3GM081, exp. 07-01-2014
Distribution pattern: Worldwide Distribution - USA (Nationwide) and Internationally to Australia Austria Belgium Canada Czech Republic Finland France Germany Great Britain Italy Japan Netherlands New Zealand Norway Portugal Slovak Republic Slovenia South Korea Spain Switzerland
Derived failure modes
-
Unknown
Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.