The Recall Desk
HighFDA (Devices)·Z-2551-2023·Announced 2023-09-20

Landauer nanoDot radiation dosimeters recalled for accuracy drift

Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may read outside the specified ±5.5% accuracy range due to a potential non-conformance in the Optical Stimulated Luminescence material.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall affecting a risk-of-harm product (radiation dosimeter) where accuracy is critical to function. No illnesses, injuries, or hospitalizations have been reported. Per the rubric, risk-of-harm products without reported injury are High (3), not Severe.

Plain-English summary

Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters (Model 03066-OTO), which are used with microSTAR readers. All batch numbers distributed worldwide are affected.

Investigation found that some dosimeters may operate outside the specified accuracy range of ±5.5%. The issue is a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in the dosimeter. The OSL material is stimulated by beaming after radiation exposure and emits fluorescence proportional to the radiation dose received.

The recalled product

Product
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Dosimeter
Hazard
  • accuracy-drift
  • osl-defect

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 (2)

  • UDI/DI 0860003399903
  • all batch numbers

Distribution

Distribution scope not specified by the agency.

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