The Recall Desk
HighFDA (Devices)·Z-2542-2023·Announced 2023-09-20

Radiation Dosimeter Accuracy Issue Recall for nanoDot D2DNS

Landauer is recalling nanoDot D2DNS radiation dosimeters due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.

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 affecting a risk-of-harm product. Inaccurate radiation dosimeter readings could result in inadequate radiation exposure assessment, though no illnesses or injuries have been reported to date.

Plain-English summary

Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters (Model Numbers 03055-1MO, 03055-3MO, 03055-OTO, and 03055-SMO) due to a potential non-conformance in the Optical Stimulated Luminescence (OSL) material. This material is responsible for emitting fluorescence proportional to radiation exposure when read by microSTAR readers.

Some recalled units may measure radiation exposure outside the specified accuracy range of +/-5.5%. This could result in inaccurate dose readings for radiation monitoring purposes.

Approximately 60 units were distributed worldwide. If you use these dosimeters for radiation monitoring, contact Landauer to determine if your units are affected and to obtain corrective action.

The recalled product

Product
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Monitoring
Hazard
  • measurement-inaccuracy
  • radiation-exposure

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

Same category