Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 1069775…

Recall date

June 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0515-2018

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

US and OUS.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.