Siemens Healthcare Diagnostics, Inc. recalls Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

Recall date

May 7, 2020

Source

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

Recall number

Z-2405-2020

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Ten…

Why it was recalled

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 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 IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026