Recall Z-2899-2016
Siemens Healthcare Diagnostics, Inc · initiated August 8, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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)
Codes / lots: Kit Lots ending in 63 and 64 as follows: 65710A63, 77825A63, 99481A64, 08835A64, 22955A64
Reason for recall
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
FDA-determined cause: Nonconforming Material/Component
Action taken
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 restored with the release of Calibrator U kit lots ending in 65. Customers may continue to use Calibrator U lots CU63 and CU64 with any indate reagent kit lot, current QC ranges and current Master Curve Material lot 45719. Revised QC targets and ranges are located on the Bio-Rad website at QCnet.com for use with CU65 and higher. For further questions, please call (508) 668-5000.
Details
- Recall number
- Z-2899-2016
- Initiated
- August 8, 2016
- Terminated
- October 3, 2018
- Product code
- DDR – Myoglobin, Antigen, Antiserum, Control
- Quantity
- 2,248 kits
- Distribution
- Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador India Japan Korea Mexico Malaysia Peru Philippines Saudi Arabia Singapore Taiwan Vietnam South Africa
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA