Home / Recalls / Medical Devices
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532
Recalled March 16, 2016 · FDA recall Z-1079-2016 · Siemens Healthcare Diagnostics
Hazard
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay · FDA Class II
Units
519 pack
Sold at
Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA
Description
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Product
Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →