Recall Z-0652-2017 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
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
| Date | Sep 15, 2016 |
| Status | Terminated |
| Reason | Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082. |
| Root cause | Under Investigation by firm |
| Action | Siemens mailed an Urgent Medical Device recall notification letter on September 19, 2016 to notify affected customers who purchased the product and to make them aware of the potential risk to health and the actions to be taken. For questions regarding tis recall. For questions regarding this recall call 1-800-441-9250. |
| Quantity | 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 Swit |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061838 | DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 Dade Behring, Inc., Aug 21, 2006 |