Recall Z-1712-2017 ยท JIS Calibrator, Primary
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
| Date | Mar 15, 2017 (initiated Feb 23, 2017) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042. |
| Root cause | Under Investigation by firm |
| Action | Siemens mailed an Urgent Medical Device Correction Notice to affected customers on 02/21/2017. The notice informed calibrator customers of the reason for the correction, risk to health, and actions to be taken by customers who are in the process of converting from the fixed factor to the enzyme calibrated assay and information for customers who had already converted, until the investigation is complete. |
| Quantity | 314 calibrators |
| Distribution | Worldwide Distribution - United States Nationwide: Denmark Sweden Norway Great Britain Belgium Netherlands Spain Israel Switzerland France Portugal Greece Germany Slovenia Czech Republic Hong Kong Colombia Korea Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103836 | ENZYME II CALIBRATOR Siemens Healthcare Diagnostics, Inc., Feb 16, 2011 |