Agency classClass IIOur severity:High FDA (Devices)·Z-2553-2023·Announced 2023-09-20

Radiation Dosimeter Kit Recalled Due to Potential Accuracy Drift

Landauer is recalling nanoDot radiation dosimeter kits (16,760 units distributed worldwide) because some units may measure radiation exposure outside specified accuracy tolerances, potentially affecting dose measurement accuracy.

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 recall of a risk-of-harm medical device with no reported injuries or illnesses. The hazard is potential accuracy drift that could affect radiation dose measurements. Since no hospitalizations have been reported and the harm is theoretical rather than confirmed, this meets the rubric criteria for Score 3 (High).

Plain-English summary

Landauer is recalling nanoDot radiation monitoring dosimeter kits (Model 03500-000, containing nanoDot A, B, and C units) that are used with microSTAR readers. The recall affects approximately 16,760 units distributed worldwide.

The recalled units may potentially measure radiation exposure outside the specified accuracy range of +/-5.5%. Investigation identified a non-conformance in the Optical Stimulated Luminescence (OSL) material used in the dosimeter, which emits fluorescence proportional to radiation exposure and is used to calculate dose measurements.

The recalled product

Product: nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation Dosimeter
Hazard: measurement-error
calibration-defect
Affected units: 16,760

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

See all →

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 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 error