Device Recall Siemens ADVIA Centaur XP and ADVIA Centaur CP Progesterone Assay 의 리콜

Recall

70470

Class 2

Z-1231-2015

2015-01-27

2015-03-02

Terminated

United States

2016-03-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133848

Advia centaur systems progesterone kit lots ending in 268 have a high bias on results greater than 30 ng/ml (95.4 nmol/l).

Siemens issued an Urgent Medical Device Correction (UMDC) was sent to affected Siemens Healthcare Diagnostics customers in the United States on January 27, 2015 to be delivered to customers on January 28, 2015. An Urgent Field Safety Notice (U FSN) was sent out for distribution to all customers outside the United States on January 27, 2015. These notices inform the customer of the potential to observe a high bias on patient sample with results greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. To mitigate the bias, Siemens instructs customers to dilute samples with values greater than 30 ng/ml when using ADVIA Centaur Systems Progesterone kit lots ending in 268. In addition, Siemens informs customers to continue to follow Urgent Medical Device Correction 10819675, Rev. A and Urgent Field Safety notice 10819674, Rev A (Information Regarding the ADVIA Centaur Systems Calibrator E), dated September 2014. Fax-back forms to be returned to confirm that the customers received the Urgent Medical Device Correction.