Dimension Vista 500 recall: Contamination
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
Why was Dimension Vista 500 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374
- Product
- Dimension Vista 500, Analyzer, chemistry Model no. 10284473
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 5373
- Distribution
- Nationwide domestic distribution. Worldwide foreign distribution.
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)