Recall Z-0864-2010 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista 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), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System
| Date | Feb 26, 2010 (initiated Aug 31, 2009) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001. |
| Root cause | Other |
| Action | An Urgent Field Safety Notice dated August 31, 2009, was issued to all affected customers. Customers were instructed to discontinue the use of Dimension Vista System CHEM 1 Cal lot 9DM001 and discard any remaining product. If customers have any question they can contact Technical Solutions at 1-800-241-0420. |
| Quantity | 1474 Cartons |
| Distribution | Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia. |
| 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 |