CLASS II Device recall · Reported 27 Mar 2019 · FDA Enforcement Report
Dimension Vista 500, Analyzer, chemistry recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista 500, Analyzer, chemistry, distributed nationwide in the US. The recall was initiated on 12 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1014-2019
- FDA event ID
- 81955
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Dec 2018
- FDA classified
- 15 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Dec 2018 | Recall initiated by company | |
| 15 Mar 2019 | Classified by FDA | +93 days |
| 27 Mar 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
Where it was distributed
Nationwide domestic distribution. Worldwide foreign distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374
Where was it sold?
Nationwide domestic distribution. Worldwide foreign distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81955This product is part of a recall event; the main page for the event is Dimension Vista 1500, Analyzer, chemistry recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dimension Vista 1500, Analyzer, chemistry recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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