510(k) · Cleared
Recalled · 2008Liaison 25 OH Vitamin D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · MRG System, Test, Vitamin D
Cleared on Feb 12, 2004 after a 154-day review. The FDA summary names its predicate without a number. 29 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 12, 2004
- Review
- 154 days
- Class
- Class II
- Product code
- MRG
- Recalls
- 4
- Predicates
- 0
29 later devices descend from it, 3 citing it directly.
- This deviceK032844 Liaison 25 OH Vitamin DDiaSorin, Inc. · 2004
- Descendant · cites it directly · 24 of its ownK071480 Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen…DiaSorin, Inc. · 2007
- Descendant · 2 generations on · 11 of its ownK110619 Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D…Biokit, S.A. · 2011 · Recalled
- Descendant · 3 generations on · 8 of its ownK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
- Descendant · 2 generations on · 8 of its ownK112725 Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc. · 2012
- Descendant · 4 generations on · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K071480Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models…DiaSorin, Inc. · 2007 · cites it directly24descendants
- K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsBiokit, S.A. · 2011 · 2 generations on11descendants
- K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics · 2012 · 3 generations on8descendants
- K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc. · 2012 · 2 generations on8descendants
- K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032844 | Liaison 25 OH Vitamin D | DiaSorin, Inc. | 2004 | — |
| +1 | K071480 | Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set… | DiaSorin, Inc. | 2007 | — |
| +2 | K110619 | Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin… | Biokit, S.A. | 2011 | 1 |
| +3 | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3… | Roche Diagnostics | 2012 | — |
| +2 | K112725 | Liaison 25 OH Vitamin D Total Assay | DiaSorin, Inc. | 2012 | — |
| +4 | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D… | Roche Diagnostics | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRG device
- #1 K221817 ALFIS Vitamin D, ALFIS-3 Analyzerscore 8.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | DiaSorin 25-Hydroxyvitamin D 125I RIA Named without a submission number |
What descends from it? (29)
See all 293 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2008 | Not classified | Z-1042-2009 | Device Design | DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer. |
| Feb 1, 2008 | Not classified | Z-1240-2008 | Nonconforming Material/Component | Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high. |
| Feb 14, 2005 | Not classified | Z-0638-05 | Other | An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A… |
| Feb 14, 2005 | Not classified | Z-0637-05 | Other | Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071480 (DiaSorin, Inc., 2007) has gone furthest, with 24 descendants of its own.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRG
120in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRG
29in 2025
MAUDE reports naming product code MRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 227 | 0 | 1 |
| 2012 | 3 | 122 | 3 | 23 |
| 2013 | 7 | 231 | 1 | 21 |
| 2014 | 6 | 159 | 0 | 14 |
| 2015 | 3 | 264 | 0 | 18 |
| 2016 | 3 | 147 | 2 | 14 |
| 2017 | 3 | 120 | 0 | 21 |
| 2018 | 2 | — | 2 | 75 |
| 2019 | 1 | — | 0 | 38 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 2 | — | 0 | 22 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 2 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LIAISON® Control 25 OH Vitamin D Set is intended for use as assayed quality control materials to monitor the accuracy and precision of the LIAISON® 25 OH Vitamin D immunoassay.
This kit is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032844: Liaison 25 OH Vitamin D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032844
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026