The Recall Desk
HighFDA (Devices)·Z-2545-2023·Announced 2023-09-20

Radiation Dosimeter Recall: nanoDot D2DXN Units May Have Inaccurate Readings

Landauer is recalling nanoDot D2DXN radiation dosimeters worldwide 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: FDA Class II recall of radiation monitoring equipment with a potential measurement accuracy defect that affects safety-critical occupational monitoring. While no illnesses have been reported, inaccurate dosimetry represents a genuine risk-of-harm scenario that could lead to undetected radiation exposure.

Plain-English summary

Landauer is recalling nanoDot D2DXN radiation monitoring dosimeters worldwide. The recall affects Model Numbers 03060-1MO, 03060-3MO, 03060-OTO, and 03060-SMO, which are used with microSTAR readers for personal radiation dosimetry.

Landauer identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in these dosimeters. As a result, some units may measure radiation exposure outside the specified accuracy range of +/-5.5%, potentially leading to inaccurate exposure readings.

Inaccurate radiation dosimetry could result in inadequate detection and recording of radiation exposure for workers who rely on these devices for occupational safety monitoring. No illnesses or injuries have been reported in connection with this defect.

The recalled product

Product
nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Hazard
  • measurement-inaccuracy
  • radiation-dosimetry-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.