The Recall Desk
HighFDA (Devices)·Z-2567-2023·Announced 2023-09-20

Landauer nanoDot radiation dosimeters may be outside accuracy specifications

Landauer is recalling nanoDot D2DNS radiation dosimeters that may be outside the specified +/-5.5% accuracy range. The issue involves a potential non-conformance in the optical measurement 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 a Class II FDA recall. No illnesses or injuries have been reported. The hazard is measurement inaccuracy in radiation dosimeters, categorized as risk-of-harm without reported injury, which the rubric caps at severity level 3.

Plain-English summary

Landauer is recalling its nanoDot D2DNS radiation monitoring dosimeters, Model Numbers 18130-000, 18130-KIT, and 18130-SET. These devices measure radiation exposure and are used with microSTAR readers.

Some devices may be outside the specified accuracy range of +/-5.5%. The issue is a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which emits fluorescence when exposed to light after receiving radiation exposure. The reader uses this fluorescence signal to calculate the radiation dose received.

Approximately 3,570 units have been distributed worldwide (all batch numbers under UDI/DI 0860003399903). The FDA classified this as a Class II recall. No illnesses or injuries have been reported related to this issue.

The recalled product

Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Monitoring Equipment
Hazard
  • measurement-inaccuracy
  • osl-material-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.

Related recalls

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