Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 27, 2019
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
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…
Siemens Healthcare Diagnostics, Inc. recalled Dimension Vista 500, Analyzer, chemistry Model no. 10284473 - a moderate-severity action.
Dimension Vista 500, Analyzer, chemistry Model no. 10284473 was recalled by Siemens Healthcare Diagnostics, Inc. in March 27, 2019. Reason: When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyc…. Check the official notice for the remedy. Verify recall #Z-1014-2019 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyc….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- March 27, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1014-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1014-2019) was formally reported on March 27, 2019, with the manufacturer initiating the action on December 12, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Newark, DE. Federal records list the affected scope as 5373.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Nationwide domestic distribution. Worldwide foreign distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5373
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1014-2019 |
| Date reported | March 27, 2019 |
| Date initiated | December 12, 2018 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Newark, DE |
| Affected scope | 5373 |
| Distribution | Nationwide domestic distribution. Worldwide foreign distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1014-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Dimension Vista 500, Analyzer, chemistry Model no. 10284473. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 5373.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2019. Severity: Moderate. Recall number: Z-1014-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide domestic distribution. Worldwide foreign distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1014-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 27, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.