Home › Device types › MRG
System, Test, Vitamin D
FDA product code MRG · Class 2 · Clinical Chemistry
75
Registered devices
379
Adverse events
25
Recalls
46
510(k) clearances
Devices with this code
ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Set — CLEARCHEM DIAGNOSTICS INC.FastPack® IP Vitamin D Kit Complete — QUALIGEN INC.25 OH Vitamin D Total (90') ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungLIAISON® 25 OH Vitamin D TOTAL Assay — Diasorin Inc.FREND Vitamin D — NanoEnTek, Inc.Access 25(OH) Vitamin D Total — Beckman Coulter, Inc.ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Kit — CLEARCHEM DIAGNOSTICS INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Atellica™ IM VitD — Siemens Healthcare Diagnostics Inc.Vit D Direct AccuBind ELISA Test System - 960 wells — MONOBIND, INC.Atellica IM VitD — Siemens Healthcare Diagnostics Inc.Alinity — ABBOTT IRELAND1,25 Dihydroxy Vitamin D RIA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDAtellica™ IM VitD — Siemens Healthcare Diagnostics Inc.IDS-iSYS 25 VitDS Calibrator Set — IMMUNODIAGNOSTIC SYSTEMS LIMITED25OH Vitamin D Total ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Monobind AccuBind Vitamin D ELISA Kit - 96 Wells — MONOBIND, INC.Vit D Direct AccuBind ELISA Test System - 96 wells — MONOBIND, INC.1,25 Dihydroxy Vitamin D RIA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDMicroVue — QUIDEL CORPORATIONADVIA Centaur® VitD Diluent Bottle — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbH25-OH Vitamin D ELISA — EUROIMMUN Medizinische Labordiagnostika AG25OH Vitamin D Total — Diasource Immunoassays S.A. SA
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.