Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2543-2023·Announced 2023-09-20

Landauer nanoDot radiation dosimeters recalled for potential accuracy deviation

Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a potential accuracy deviation in the radiation monitoring device's OSL material, representing a theoretical rather than confirmed risk of harm.

Plain-English summary

Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters, including Model Numbers 03056-000, 03056-1MO, 03056-3MO, and 03056-KIT, used with microSTAR readers. Approximately 535,643 units distributed worldwide are involved in the recall.

Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in the dosimeters. As a result, some nanoDots may provide radiation exposure readings outside the specified accuracy range of +/-5.5%.

The OSL material is exposed to measure radiation and then emits fluorescence proportional to the exposure. The potential defect in this material is the basis for the recall.

The recalled product

Product: nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation Monitoring Device
Hazard: measurement-error
accuracy-deviation
Affected units: 535,643

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