Device Recall Siemens 의 리콜

Recall

65562

Class 2

Z-1960-2014

2013-06-25

2014-07-02

Terminated

United States

2016-05-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119579

Advia centaur homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the instructions for use (ifu).

Siemens Healthcare sent an Urgent Field Safety Notice that was sent to all affected Siemens Healthcare Diagnostics customers in the United States on June 25, 2013. The Urgent Field Safety Notice was sent out for distribution to all customers outside the United States on June 24, 2013. These notices inform the customer that the 1:10 diluted patient recovery is lower than reported in the Instructions for Use (IFU). Customers should discontinue use of both manual and on board 1:10 dilutions of samples with the ADVIA Centaur HCY assay. Customers can continue to use a manual or on board 1 :2 dilution for samples with results outside of the assay range. Siemens has confirmed the performance at the 1 :2 dilution level meets the IFU ranges. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Technical Solutions Center or your local Siemens technical support representative. For further questions please call (508) 668-5000.