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.
Enforcement
- Recall Number
- Z-2720-2014
- Event ID
- 69063
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 8, 2014
- Initiation Date
- August 18, 2014
- Classification Date
- September 29, 2014
- Termination Date
- February 2, 2015
- Address
- 500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States
Description
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.
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.
lot 3GM081, exp. 07-01-2014
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
9769 Total (6000 US)