Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Recall date

January 12, 2020

Source

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

Recall number

Z-1421-2020

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Domestic distribution nationwide. Worldwide foreign distribution.

Why it was recalled

Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

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 CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143