Recall Z-1216-2017 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.
| Date | May 5, 2016 |
| Status | Terminated |
| Reason | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots. |
| Root cause | Under Investigation by firm |
| Action | Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue. For further questions, please call (800) 441-9250. |
| Quantity | 13,147 units |
| Distribution | Distributed throughout the United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103612 | DIMENSION VISA ENZ 2 CAL Siemens Healthcare Diagnostics, Inc., Jan 25, 2011 |