Recall Z-1076-2014 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
| Date | Feb 24, 2014 (initiated Jan 6, 2014) |
| Status | Terminated |
| Reason | Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL). |
| Root cause | Nonconforming Material/Component |
| Action | A recall notification letter, dated January 2014, was sent to Users. |
| Quantity | 3496 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061923 | DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) Dade Behring, Inc., Aug 25, 2006 |