The Recall Desk
ModerateFDA (Devices)·Z-2569-2023·Announced 2023-09-20

Radiation monitoring dosimeters recalled for potential measurement inaccuracy

Landauer is recalling QC (Cs-137) nanoDot D2DNS radiation dosimeters worldwide because some units may operate outside the specified accuracy range. The recall affects 10,741 units with all batch numbers.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II with no reported illnesses, injuries, or actual exposure incidents. The defect is measurement inaccuracy in a safety-monitoring device—a precautionary quality issue rather than a direct physical hazard.

Plain-English summary

Landauer is recalling the QC (Cs-137) nanoDot D2DNS radiation monitoring dosimeter, including model numbers 18135-000, 18135-KIT, and 18135-SET. These devices measure occupational radiation exposure using Optical Stimulated Luminescence (OSL) technology. The recall applies to all batch numbers and affects 10,741 units distributed worldwide.

Landauer received reports indicating that some nanoDots may operate outside the manufacturer's specified accuracy range of ±5.5%. Investigation identified a potential non-conformance in the OSL material used by the dosimeters, which could result in inaccurate radiation exposure readings.

This recall affects organizations and individuals worldwide that rely on these dosimeters for radiation exposure monitoring and occupational safety assessments.

The recalled product

Product
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Hazard
  • measurement-inaccuracy
  • occupational-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.