Recall Z-2899-2016 ยท DDR Myoglobin, Antigen, Antiserum, Control
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
| Date | Aug 8, 2016 |
| Status | Terminated |
| Reason | Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction (UMDC) to customers in the US on August 8, 2016, to be delivered to customers on August 9, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on August 8, 2016. The communications notify customers of the failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization. The communications also inform customers that analytical sensitivity and alignment to the internal standardization will be re |
| Quantity | 2,248 kits |
| Distribution | Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador India Japan Kore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122599 | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR Siemens Healthcare Diagnostics, Inc., Oct 3, 2012 |