Device Recall ADVIA Centaur Systems TnlUltra assay 의 리콜

Recall

68520

Class 2

Z-1991-2014

2014-05-30

2014-07-02

Terminated

United States

2016-02-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128130

The solid phase reagent in some of the advia centaur¿ tni -ultra readypacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.

An Urgent medical Device Correction (UMDC) was mailed, via FedEx, to all affected Siemens Healthcare Diagnostics customers in the United States on May 30, 2014 for customer receipt on June 2, 2014. All international customers were provided with a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer is asked to complete a fax-back form. This notice informed the customers of the potential for incorrect control and patient results due to solid phase which is darker in appearance. The notice instructs customers to place one TnI-Ultra ReadyPack on the system at a time and to calibrate and run controls on each ReadyPack to ensure accurate control and patient values. Patient TnI-Ultra results produced with this assay are acceptable if they follow acceptable calibration with valid quality control results. Upon receipt of kit lots ending in 086 and higher, calibration of each ReadyPack is not required. This notice should be reviewed with the facility's laboratory or medical director.