Recall Z-0164-2015 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
| Date | Dec 16, 2014 (initiated Sep 26, 2014) |
| Status | Terminated |
| Reason | Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 26, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 26, 2014. These notices inform the customer of the positive bias with ADVIA Centaur Systems Cortisol and Progesterone when calibrated with Calibrator E kit lots ending in 38 and 39.Customers may continue use of the affected lots as the clinical utility of the assay is not impacted. The communications also provide informat |
| Quantity | Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF) |
| Distribution | Nationwide including Puerto Rico. Worldwide: Afghanistan, Armenia, Austria, Bahrain, Belgium, Bulgaria, Burkina Faso, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iran, Iraq, Ireland, Italy, Jordan, Kazakhstan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932955 | CIBA CORNING ACS PROGESTERONE IMMUNOASSAY Ciba Corning Diagnostics Corp., Aug 2, 1993 |