Z-1014-2019 Class II Terminated
FDA device recall Z-1014-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on Dec 12, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 27, 2020). Affected quantity: 5373.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2019
- Initiation Date
- Dec 12, 2018
- Termination Date
- Apr 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5373
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.
Distribution Pattern
Nationwide domestic distribution. Worldwide foreign distribution.
Code Information
Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1014-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026