FDA Device recall Z-1015-2019
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
- FDA Device
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 by Siemens Healthcare Diagnostics, citing when the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously el….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1015-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-12 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
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.
Identifiers
| code_info | Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477…Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1015-2019%22
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