FDAFDA · Food and drugs·Recall number Z-2538-2023
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers
Published September 20, 2023 · Recall initiated: July 12, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Landauer
- Distributor
- Worldwide
- Lot
- UDI/DI 0860003399903, all batch numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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