Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 AD…

Recall date

February 4, 2016

Source

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

Recall number

Z-1079-2016

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

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

Why it was recalled

ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay

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

What was recalled

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