The Recall Desk
HighFDA (Devices)·Z-2561-2023·Announced 2023-09-20

Radiation dosimeter may report inaccurate exposure readings

Landauer recalls nanoDot D2DNN radiation dosimeters worldwide due to potential accuracy degradation that may cause incorrect exposure readings.

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 recall of a risk-of-harm product where measurement accuracy is critical to worker safety. No injuries or illnesses have been reported, but inaccurate radiation dosimetry could result in under-reporting of occupational radiation exposure.

Plain-English summary

Landauer is recalling the nanoDot D2DNN radiation monitoring dosimeter (model numbers 04293-000 and 04293-KIT) due to a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in the device. Some units may have accuracy readings outside the specified tolerance range of ±5.5%, which could result in inaccurate radiation exposure measurements.

Approximately 632,928 units have been distributed worldwide. The dosimeters are used in occupational radiation monitoring in conjunction with microSTAR readers. Inaccurate readings could fail to properly reflect worker radiation exposure levels.

Users who have received nanoDot D2DNN dosimeters should contact their radiation safety officer or Landauer for guidance on device validation or replacement.

The recalled product

Product
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Hazard
  • measurement-accuracy
  • radiation-monitoring

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.