Liaison® 25 OH Vitamin D Total Assay
Catalogue number 310600, listed by Diasorin Inc., United States, under System, Test, Vitamin D. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
6510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Diasorin Inc., United States |
|---|---|
| FDA product code | MRG |
| Device type | System, Test, Vitamin D |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1825 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2026-01-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 6 |
| Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | 3 |
| Maglumi 25-OH Vitamin D | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 3 |
| Architect | Abbott Medical | 3 |
| Atellica™ IM VitD | Siemens Healthcare Diagnostics Inc | 2 |
| 1,25 Dihydroxy Vitamin D RIA | Immunodiagnostic Systems Ltd. | 2 |
| Maglumi 2000 25-OH Vitamin D | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
| Alinity | Abbott Ireland | 2 |
| Architect | Abbott Ireland | 2 |
| Elecsys Vitamin D total II | Roche Diagnostics Gmbh | 2 |
| IDS-iSYS 25 VitDS | Immunodiagnostic Systems Ltd. | 2 |
| Elecsys Vitamin D total III | Roche Diagnostics Gmbh | 2 |
Showing 12 of 50. All products under System, Test, Vitamin D
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141463 | 2014-12-10 |
| K132492 | 2013-09-05 |
| K112725 | 2012-01-20 |
| K071480 | 2007-10-01 |
| K032844 | 2004-02-12 |
| K014030 | 2002-03-26 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-02-01 | Not classified | Nonconforming Material/Component | Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high. | 2,267 kits | 2008-10-31 |
| 2007-08-21 | Not classified | Other | 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer. | 117 kits | 2008-10-17 |
| 2006-06-05 | Not classified | Other | Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered | 715 | 2007-06-25 |
| 2005-02-14 | Not classified | 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 curv | 31 kits | 2006-07-22 |
| 2005-02-14 | Not classified | 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. | 131 | 2006-07-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.