The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2571-2023·Announced 2023-09-20

Landauer nanoDot dosimeters recalled for potential accuracy deviation

Landauer has recalled nanoDot radiation dosimeters due to potential accuracy deviations in the Optical Stimulated Luminescence material used to measure radiation exposure. Affected 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: This FDA Class II medical device recall affects radiation dose measurement accuracy with no reported illnesses or injuries. Per the severity rubric, recalls with theoretical hazards and no reported harm score at most 3 (High). Inaccurate radiation dosimetry could lead to undetected or improperly assessed radiation exposure.

Plain-English summary

Landauer has recalled the Constancy (80 kVp) nanoDot D2DNN radiation monitoring dosimeter (Models 18150-000 and 18150-KIT) due to a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used to measure radiation exposure.

The nanoDot dosimeter is used with microSTAR readers to measure occupational and medical radiation exposure. The OSL material fluoresces in proportion to radiation dose, and this fluorescence is read to determine exposure levels. Some recalled units may read outside the specified accuracy range of +/-5.5%.

The recall affects 512 units distributed worldwide (UDI/DI 0860003399903, all batch numbers). No illnesses or injuries have been reported.

Healthcare facilities and occupational health programs using these dosimeters should discontinue use of affected units and contact Landauer for guidance on replacements and next steps.

The recalled product

Product
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Dosimetry
Hazard
Affected units
512

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 →

Related recalls

Same manufacturer · Landauer

See all →

Similar recalls