Z-1015-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- December 12, 2018
- Termination Date
- April 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5373
Product Description
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
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