Agency classClass IIOur severity:High FDA (Devices)·Z-2547-2023·Announced 2023-09-20

Radiation Monitoring Dosimeter Potential Accuracy Error: Worldwide Landauer nanoDot Recall

Landauer is recalling nanoDot D2DXS radiation monitoring dosimeters worldwide due to a potential non-conformance that could cause some units to measure radiation exposure outside the specified +/-5.5% accuracy range.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 an FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The hazard is a potential measurement inaccuracy in radiation monitoring equipment, which poses a risk of harm through improper radiation protection decisions but no actual harm has been reported. Per the rubric, this qualifies as High: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Landauer is recalling nanoDot D2DXS radiation monitoring dosimeters (model numbers 03062-1MO, 03062-3MO, 03062-OTO, and 03062-SMO) with UDI/DI 0860003399903 in all batch numbers. These are personal radiation dosimeters used with microSTAR readers to monitor occupational radiation exposure.

A potential non-conformance was identified in the Optical Stimulated Luminescence (OSL) material component of the dosimeters. This defect could cause some devices to measure radiation exposure outside the specified accuracy range of ±5.5%, resulting in inaccurate exposure readings that do not meet product specifications.

Individuals and facilities using these dosimeters should immediately contact Landauer to report their use and receive replacement or corrective instructions. Inaccurate radiation dosimetry could compromise radiation protection decisions and worker safety monitoring. The recall affects all batch numbers of the affected models distributed worldwide.

The recalled product

Product: nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation Monitoring Equipment
Hazard: measurement-inaccuracy
radiation-monitoring-error

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.

Part of a larger recall action

This product is one of 38 recalled by Landauer under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Same manufacturer · Landauer

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Moderate
Landauer microStar Reader dosimetry system discontinued for medical applications
FDA (Devices) · 2024-03-27
High
Landauer microSTARii reader recalled for measurement inaccuracy
FDA (Devices) · 2024-01-03
High
Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
FDA (Devices) · 2023-09-20
High
Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2023-09-20
High
Landauer nanoDot dosimeters recalled for potential accuracy deviation
FDA (Devices) · 2023-09-20

Same hazard · measurement inaccuracy