Siemens Healthcare Diagnostics ADVIA Centaur Calibrator U 의 리콜

Recall

74951

Class 2

Z-2899-2016

2016-08-08

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148887

Failure of analytical sensitivity with calibrator u kit lots ending in 63 and 64 and a drift from the internal standardization.

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.