The Recall Desk
HighFDA (Devices)·Z-2555-2023·Announced 2023-09-20

Landauer nanoDot B Radiation Dosimeters Recalled for Measurement Accuracy

Landauer nanoDot B radiation dosimeters may have measurement inaccuracies outside the specified +/-5.5% range, potentially compromising radiation exposure monitoring. 16,820 units worldwide are affected.

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 medical device recall involving a radiation monitoring dosimeter with potential measurement inaccuracy. The source text does not report any illnesses or injuries, but inaccurate radiation exposure measurements in an occupational safety device pose a material risk to worker health. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Landauer is recalling nanoDot B radiation monitoring dosimeters, Model 03502-000, used to measure occupational radiation exposure. The devices use Optical Stimulated Luminescence (OSL) technology to detect and quantify radiation exposure. Approximately 16,820 units have been distributed worldwide.

Some nanoDot B dosimeters may have a non-conformance in the OSL material that results in measurement accuracy outside the specified range of plus or minus 5.5%. This means the dosimeters could provide inaccurate radiation exposure readings.

Healthcare facilities, industrial sites, research laboratories, and other organizations using nanoDot B dosimeters for radiation safety monitoring are potentially affected. Workers who rely on these devices for occupational radiation exposure tracking should verify that their units function correctly.

Users should contact Landauer to determine whether their specific units are affected and to receive corrected dosimeters. Landauer is providing support to affected customers.

The recalled product

Product
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Dosimeter
Hazard
  • measurement-inaccuracy
  • radiation-exposure-risk

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.

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