Dimension Vista 500 — Class II medical device recall Z-1014-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-03-27, distributed nationwide. When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyce
| Recall number | Z-1014-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2018-12-12 |
| Classified | 2019-03-15 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2020-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 5,373 |
| Reason classes | potency |
| Lot numbers | F7MA50339, F7MA56608, F7NA62488, F8AA13966, F8AA93567, F8BA20457, F8BA35774, F8DA59251, F8HA64477, F8HA79819, F8HA91305, F8JA97876, F8MA06374 |
| Model numbers | 10284473 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1014-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.