Agency classClass IIOur severity:High FDA (Devices)·Z-2554-2023·Announced 2023-09-20

Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy

Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.

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 medical device recall of a radiation dosimeter with potential accuracy non-conformance. The source does not report illnesses or injuries. This constitutes a risk-of-harm product where injury has not yet been reported, per the Score 3 criterion.

Plain-English summary

Landauer is recalling nanoDot A radiation monitoring dosimeters, Model Number 03501-000, used with microSTAR readers. Approximately 16,820 units with UDI/DI 0860003399903 are affected, all batch numbers, distributed worldwide.

The recall was initiated after Landauer received reports that some nanoDots may measure radiation exposure outside the specified accuracy range of plus or minus 5.5%. Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which is stimulated by light after radiation exposure and emits fluorescence proportional to the absorbed radiation dose.

Radiation monitoring dosimeters are used in occupational and industrial settings to measure worker radiation exposure.

The recalled product

Product: nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation Dosimeter
Hazard: measurement-inaccuracy
dosimeter-defect
Affected units: 16,820

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 Radiation Dosimeters Recalled Due to Potential Accuracy Issues
FDA (Devices) · 2023-09-20
High
Landauer nanoDot dosimeters recalled for potential accuracy deviation
FDA (Devices) · 2023-09-20

Same hazard · measurement inaccuracy