FDA-Device2019-03-27Class II
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
Siemens Healthcare Diagnostics, Inc.
Hazard
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.
Sold states
Nationwide domestic distribution. Worldwide foreign distribution.
Affected count
5373
Manufactured in
500 Gbc Dr Ms 514, N/A, Newark, DE, United States
Products
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1015-2019Don't want to check this manually?
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