FDA-Device2018-02-14Class II
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Siemens Healthcare Diagnostics, Inc
Hazard
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).
Sold states
US and OUS.
Affected count
5992 units (US and OUS)
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0515-2018Don't want to check this manually?
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