Agency classClass IIOur severity:High FDA (Devices)·Z-2573-2023·Announced 2023-09-20

Landauer NanoDots radiation dosimeters recalled for potential accuracy defect

Landauer is recalling NanoDots radiation monitoring dosimeters worldwide due to potential accuracy defects. Some units may fall 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: This FDA Class II recall involves potential accuracy defects in radiation monitoring devices with no reported illnesses or injuries. The hazard is theoretical—a dosimeter outside the specified accuracy range poses a risk of inaccurate radiation dose measurements—satisfying the rubric criterion for high-risk products without confirmed harm.

Plain-English summary

Landauer is recalling approximately 18,333 NanoDots radiation monitoring dosimeters that were distributed worldwide. These devices are used with microSTAR readers to monitor radiation exposure.

The recall was initiated following reports indicating that some NanoDots may fall outside the specified accuracy range of +/-5.5%. An investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which is responsible for measuring radiation exposure by emitting fluorescence proportional to the dose received.

Hospitals, clinics, and healthcare workers using these dosimeters should contact Landauer for further guidance on verification, replacement, or return. Affected units can be identified using the product UDI/DI code 0860003399903, which applies to all batch numbers.

The recalled product

Product: NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge…
Manufacturer: Landauer
Category: Medical Device — Radiation dosimetry
Hazard: measurement-accuracy-defect
radiation-exposure-risk
Affected units: 18,333

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 accuracy defect