Siemens Healthcare Diagnostics, Inc. recalls Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.

Recalled May 9, 2018 · FDA recall Z-1588-2018 · Siemens Healthcare Diagnostics

Hazard

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

Units

N/A

Sold at

FL and France Spain Sweden United Kingdom Germany

Description

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

Product

Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →