Recall Z-2387-2010 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system.
| Date | Sep 9, 2010 (initiated Feb 26, 2010) |
| Status | Terminated |
| Reason | There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed. |
| Root cause | Employee error |
| Action | The recalling firm issued an Urgent field Safety Notice, dated February 2010, to all affected customers informing them of the problem. Customers have been told to run calibrators from cups when calibrating or request a replacement lot. The notification should be forwarded to that this product was further distributed to. Siemens Technical Solutions Center should be contacted at 800-441-9250, if they are any technical questions. |
| Quantity | 1310 cartons |
| Distribution | Worldwide Distribution -- USA, Austria, Germany, Netherlands, Italy, France, Denmark, Portugal, Canada, South Korea, Malaysia, Australia, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061703 | DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) Dade Behring, Inc., Aug 2, 2006 |