Agency classClass IIOur severity:High FDA (Devices)·Z-2538-2023·Announced 2023-09-20

Radiation monitoring dosimeter units recalled for potential accuracy defect

Landauer is recalling 147 nanoDot D2DNS radiation dosimeters worldwide due to potential non-conformance in the OSL material that may result in readings falling outside the ±5.5% accuracy specification.

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 a Class II medical device recall for potential measurement inaccuracy in a safety-critical radiation dosimeter. Although no illness or injury has been reported, the risk-of-harm nature of radiation dose measurement errors warrants a High severity classification.

Plain-English summary

Landauer is recalling 147 nanoDot D2DNS radiation monitoring dosimeters (Model 03033-OTO, UDI/DI 0860003399903) distributed worldwide. These dosimeters are used with microSTAR readers to measure occupational radiation exposure.

The recall stems from a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in the dosimeters. When exposed to radiation, this material emits fluorescence proportional to the dose received. Investigation revealed that some units may have OSL material that produces measurements falling outside the specified accuracy range of ±5.5%, potentially resulting in inaccurate radiation dose readings.

Workers and facilities using these dosimeters should contact Landauer to determine if their units are affected and for guidance on next steps. The recall encompasses all batch numbers of the affected model.

The recalled product

Product: nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation Safety
Hazard: measurement-error
accuracy-defect
Affected units: 147

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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Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
FDA (Devices) · 2023-09-20
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Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2023-09-20
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Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
FDA (Devices) · 2023-09-20

Same hazard · measurement error