Recall Z-1078-2016 ยท JIX Calibrator, Multi-Analyte Mixture
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in se
| Date | Mar 8, 2016 (initiated Feb 4, 2016) |
| Status | Terminated |
| Reason | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare issued an Urgent Medical Device Correction (UMDC) to all affected Siemens Healthcare Diagnostics customers in the United States on February 4, 2016 to be delivered to customers on February 5, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on February 4, 2016. These notices inform the customers of the lot to lot bias of Calibrator E with the ADVIA Centaur Testosterone assay and advise customers to move to Calibrator E kit lots ending in 44. Fax-back forms will be used to confirm that the customers received the |
| Quantity | 6455 (6 pack) |
| Distribution | Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC |
| 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 |