The Recall Desk
HighFDA (Devices)·Z-2575-2023·Announced 2023-09-20

Landauer nanoDot Radiation Dosimeter Recalled for Accuracy Defect

Landauer is recalling nanoDot radiation dosimeter adapters (EU Model VINLADA003) worldwide because some units may provide dosimetry readings outside the specified +/-5.5% accuracy range due to a non-conformance in the optical measurement material.

What this means for you

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 potential measurement accuracy defects. No illnesses or injuries have been reported; the hazard is theoretical based on potential non-conformance rather than documented harm.

Plain-English summary

Landauer is recalling nanoDot radiation dosimeter adapters (EU Model Number VINLADA003) used with microSTAR readers, distributed worldwide. All batch numbers are included in this recall.

Some nanoDots may provide dosimetry readings outside the specified +/-5.5% accuracy range. Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which is beamed after radiation exposure to emit fluorescence proportional to the dose received and measured by the reader.

The recalled product

Product
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Hazard
  • accuracy-defect
  • dosimeter-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.