Agency classClass IIOur severity:High FDA (Devices)·Z-2552-2023·Announced 2023-09-20

Radiation dosimeter recalled for potential measurement accuracy deviations

Landauer recalled nanoDot D2DNS radiation dosimeters worldwide due to potential inaccuracy in Optical Stimulated Luminescence material. 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 medical device with no reported injuries. However, radiation dosimeters are risk-of-harm products; measurement inaccuracy could compromise radiation safety decisions. This qualifies as risk-of-harm product where injury has not yet been reported per the rubric.

Plain-English summary

Landauer is recalling its QC (Cs-137) screened nanoDot D2DNS radiation dosimeter (Model Number 03067-OTO) worldwide. The dosimeter is a radiation monitoring device used with microSTAR readers to measure occupational and medical radiation exposure. All batch numbers are included in the recall.

Landauer received reports indicating some nanoDots may measure outside the specified accuracy range of ±5.5%. Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which emits fluorescence proportional to radiation exposure and is used to calculate dose readings. Inaccurate measurements could affect decisions about radiation safety and exposure management.

No illnesses or injuries have been reported in connection with this recall. Users of affected dosimeters should contact Landauer for guidance on verification or replacement.

The recalled product

Product: QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation Dosimeter
Hazard: measurement-inaccuracy
material-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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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
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Same hazard · measurement inaccuracy