Home › Device types › MRG
System, Test, Vitamin D
FDA product code MRG · Class 2 · Clinical Chemistry
78
Registered devices
379
Adverse events
25
Recalls
46
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges — FUJIREBIO INC.Vit D Direct AccuBind ELISA Test System - 480 wells — MONOBIND, INC.ADVIA Centaur® VitD — Siemens Healthcare Diagnostics Inc.Vit D Direct AccuLite CLIA Test System - 960 wells — MONOBIND, INC.Atellica IM VitD DIL — Siemens Healthcare Diagnostics Inc.Vit D Direct AccuBind ELISA Test System - 96 wells — MONOBIND, INC.Atellica™ IM VitD — Siemens Healthcare Diagnostics Inc.CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET — CAROLINA LIQUID CHEMISTRIES CORPORATIONIDS-iSYS 25 VitDS — IMMUNODIAGNOSTIC SYSTEMS LIMITEDElecsys Vitamin D total III — Roche Diagnostics GmbHVit D Direct AccuLite CLIA Test System - 96 wells — MONOBIND, INC.Alinity — ABBOTT IRELANDAlinity — ABBOTT IRELANDAtellica™ IM VitD — Siemens Healthcare Diagnostics Inc.Elecsys Vitamin D total II — Roche Diagnostics GmbH1,25 Dihydroxy Vitamin D RIA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDElecsys Vitamin D total II — Roche Diagnostics GmbHVITROS — ORTHO CLINICAL DIAGNOSTICSIDS-iSYS 25-Hydroxy Vitamin DS — IMMUNODIAGNOSTIC SYSTEMS LIMITEDLIAISON® 25 OH Vitamin D TOTAL Assay — Diasorin Inc.Atellica IM VitD — Siemens Healthcare Diagnostics Inc.Atellica IM VitD — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2018-11-21 | Abbott Ireland Diagnostics Division | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Append |
| 2018-09-11 | R & D Systems, Inc. | The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL. |
| 2018-04-27 | Roche Diagnostics Corporation | The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a d |
| 2018-04-27 | Roche Diagnostics Corporation | The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a d |
| 2017-07-07 | Qualigen Inc | Specific lots have been reported to produce falsely lower than expected results for Vitamin D |
| 2016-10-05 | Siemens Healthcare Diagnostics, Inc | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples |
| 2016-10-05 | Siemens Healthcare Diagnostics, Inc | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples |
| 2014-04-10 | Siemens Healthcare Diagnostics, Inc | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. |
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