Device Recall Siemens Healthcare ADVIA Centaur DHEA504 의 리콜

Recall

63682

Class 2

Z-0509-2013

2012-11-14

2012-12-11

Terminated

United States

2015-09-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114530

Operating range of the advia centaur systems is 18c to 30¿c (64.4¿f to 86.0¿f), a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.

Siemens Healthcare issued An Urgent Medical Device Correction Notice (for US customers) and an Urgent Field Safety Notice (for customers outside the US) dated November 5, 2012, to all affected customers. These notices inform customers who used the ADVIA Centaur BNP, BR, CA 19-9, Digitoxin, Folate, and Theophylline 2 assays to reduce their instrument operating temperature range to 20 -25 degrees C and for the DHEAS assay to reduce the instrument operating temperature range to 18 -26 degrees C when these assays are being used. These notices also direct customers to review the contents of the correction notice with their Laboratory Director or Medical Director. A confirmation fax-back form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local technical support representative. For questions regarding this recall call 508-668-5000.