Agency classClass IIOur severity:High FDA (Devices)·Z-2556-2023·Announced 2023-09-20

Radiation Monitoring Dosimeter Accuracy Issue Affects nanoDot Devices

Landauer recalled nanoDot C radiation dosimeters due to potential accuracy errors in the optical stimulated luminescence material. Affected units may provide dosimetry readings outside the specified tolerance range of +/-5.5%.

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 medical device recall with no reported hospitalizations, injuries, or deaths. The hazard is potential inaccuracy in a radiation monitoring dosimeter, representing a risk-of-harm with theoretical rather than confirmed actual harm.

Plain-English summary

Landauer issued a recall of nanoDot C radiation monitoring dosimeters (Model 03503-000), which are used with microSTAR readers. These devices are distributed worldwide and all batch numbers are affected, as indicated by UDI/DI 0860003399903.

The recall was initiated after Landauer received reports that some units may operate outside the specified accuracy range of +/-5.5%. Investigation found a potential non-conformance in the optical stimulated luminescence (OSL) material within the dosimeters. This material is designed to emit fluorescence proportional to radiation exposure, allowing measurement of radiation dose.

Due to this non-conformance, affected units may provide inaccurate radiation dosimetry readings.

The recalled product

Product: nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer: Landauer
Category: Medical Device — Radiation Monitoring
Hazard: dosimetry-error
measurement-error

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 →

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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 · dosimetry error