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Recall Observatory FDA recall evidence

Device product

Dimension Vista 500, Analyzer, chemistry Model no. 10284473

Z-1014-2019

December 12, 2018

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 81955
Status
Terminated
Classification
Class II
Quantity
5373
Official record key
device-enforcement:Z-1014-2019

Official wording

Reason: 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.

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

Distribution pattern: Nationwide domestic distribution. Worldwide foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.