Recall Z-1535-2010 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System
| Date | May 4, 2010 (initiated Oct 23, 2009) |
| Status | Terminated |
| Reason | patient results are depressed |
| Root cause | Other |
| Action | An "Urgent Field Safety Notice" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product. If you have any technical qu |
| Quantity | 1753 cartons |
| Distribution | Worldwide distribution: USA and Australia, Canada, Japan, New Zealand, South Korea, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062334 | DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 Dade Behring, Inc., Sep 22, 2006 |