Device Recall ADVIA Centaur Calibrator 30 의 리콜

Recall

78645

Class 2

Z-0515-2018

2017-06-07

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160060

Siemens healthcare diagnostics has confirmed a negative bias for advia centaur enhanced estradiol (ee2) on the advia centaur, advia centaur xp and advia centaur xpt systems when calibrating with calibrator 30 kit lots ending in 21 (c3021) as compared to calibrator 30 kit lots ending in 20 (c3020).

An Urgent Medical Device Recall letter dated June 7, 2017 was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States who have received ADVIA Centaur Systems Calibrator 30 kit lot ending in 21(C3021). These letters instruct customers who operate the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems to discontinue use of C3021 . The letters inform customers that Calibrator 30 kit lots ending in 20 (C3020) and 23 (C3023) are not impacted and can be used. The letters inform customers who operate ADVIA Centaur CP systems to continue using their inventory of C3021, as they are not impacted by this issue. All affected domestic customers were sent a hard copy of the Urgent Medical Device Recall via Federal Express. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall letter.