Agency classClass IIOur severity:High FDA (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.

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: 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
Category: Medical Device — Radiation Dosimeter
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.

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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FDA (Devices) · 2024-03-27
High
Landauer microSTARii reader recalled for measurement inaccuracy
FDA (Devices) · 2024-01-03
High
Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
FDA (Devices) · 2023-09-20
High
Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2023-09-20
High
Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
FDA (Devices) · 2023-09-20

Same hazard · measurement inaccuracy