Siemens Healthcare Diagnostics, Inc. recalls Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

Recall date

February 26, 2018

Source

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

Recall number

Z-1587-2018

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

FL and France Spain Sweden United Kingdom Germany

Why it was recalled

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

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

What was recalled

Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.