Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), 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
Reported: November 30, 2016 Initiated: September 15, 2016 #Z-0652-2017
Product Description
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), 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
Reason for Recall
Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 9,935 units
- Distribution
- Worldwide Distribution - US (Nationwide) Internationally to Australia, Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Qatar, Saudi Arabia, South Korea, Slovakia, Slovenia, Spain, and Switzerland.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), 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. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 9,935 units.
Why was this product recalled? ▼
Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2016. Severity: Moderate. Recall number: Z-0652-2017.
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