Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur XPT Immunoassay System

Recall date

April 28, 2016

Source

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

Recall number

Z-0072-2017

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN

Why it was recalled

The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.

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 XPT Immunoassay System