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Dimension Vista 500, Analyzer, chemistry Model no. 10284473

FDA Recall #Z-1014-2019 — Class II — December 12, 2018

Recall #Z-1014-2019 Date: December 12, 2018 Classification: Class II Status: Terminated

Product Description

Dimension Vista 500, Analyzer, chemistry Model no. 10284473

Reason for Recall

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.

Recalling Firm

Siemens Healthcare Diagnostics, Inc. — Newark, DE

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

5373

Distribution

Nationwide domestic distribution. Worldwide foreign distribution.

Code Information

Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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