Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista 500, Analyzer, chemistry Model no. 10284473

Recall date

December 12, 2018

Source

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

Recall number

Z-1014-2019

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Nationwide domestic distribution. Worldwide foreign distribution.

Why it was recalled

When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination.

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

What was recalled

Dimension Vista 500, Analyzer, chemistry Model no. 10284473