Ortho VITROS FSH Reagent Pack Recalled for Potential Biased Results
Ortho Clinical Diagnostics is recalling VITROS FSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than indicated.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a diagnostic device where the hazard is potential test inaccuracy due to biotin interference, with no reported injuries or illnesses.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling VITROS Immunodiagnostic Products - FSH Reagent Packs (Catalog Number 1931922). The recall involves 1,955 units distributed in the United States and internationally, including Australia, Canada, China, and various European countries. The affected product lots are identified by codes 2470, 2480, 2490, 2500, 2510, 2520, and 2530.
The recall was initiated because the firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations lower than those indicated in the current Instructions For Use (IFU). Patients taking biotin supplements could potentially receive biased sample results for the affected assays at these lower biotin concentrations.
Healthcare facilities and laboratories should stop using the affected reagent packs and contact Ortho Clinical Diagnostics for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Affected units
- 1,955
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2470 2480 2490 2500 2510 2520 2530
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ortho Clinical Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Ortho Clinical Diagnostics Inc
See all →- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateLactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- HighVITROS CHE slides can cause quality control drift with performance verifiers
FDA (Devices) · 2025-07-23
- HighVITROS CHE slides sold in Japan can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · test inaccuracy
See all →- ModerateLeadCare II Blood Lead Test Kit Recall for Inaccurate Results
FDA (Devices) · 2026-04-29
- ModerateOrtho Clinical Diagnostics Total Bili-Alkp XT Reagent Recall
FDA (Devices) · 2025-06-04
- ModerateORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide
FDA (Devices) · 2025-06-04
- HighSiemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy
FDA (Devices) · 2024-11-27
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15