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IDS-iSYS 25-Hydroxy Vitamin DS
IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-2700S · UDI-DI 05060169690400
MRG
Prescription
1
510(k) clearances
379
Adverse events
25
Recalls
51
Facilities
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 Appendix A. If a bottle n |
| 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 dosage reduction of v |
| 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 dosage reduction of v |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.