The Recall Desk
HighFDA (Devices)·Z-2570-2023·Announced 2023-09-20

Radiation monitoring dosimeters recalled for potential measurement inaccuracy

Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters worldwide due to a potential material defect that may cause readings to fall outside the specified ±5.5% accuracy range.

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: This is a Class II recall of a radiation dosimetry device where potential measurement inaccuracy poses a risk of harm to users through inadequate radiation exposure detection. The source reports no illnesses or injuries; the hazard is theoretical rather than demonstrated, placing this at the high end of precautionary recalls.

Plain-English summary

Landauer is recalling certain Calibrate (unexposed) nanoDot D2DNS radiation monitoring dosimeters used with microSTAR readers. The affected model numbers are 18140-000, 18140-KIT, and 18140-SET. A total of 659 units have been identified in this recall, distributed worldwide.

The recall was initiated following reports and investigation indicating that some dosimeters may fall outside the specified accuracy range of ±5.5%. The issue stems from a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which is beamed after radiation exposure to measure and emit fluorescence proportional to the radiation dose received. If the OSL material does not meet specifications, the dosimeter may provide inaccurate radiation exposure measurements.

Radiation dosimeters are relied upon to detect and quantify radiation exposure for safety monitoring purposes. Inaccurate measurements could fail to properly warn users of excessive radiation exposure or could mask inadequate protection measures.

Customers in possession of affected units should contact Landauer directly for remediation options, which may include replacement or recalibration.

The recalled product

Product
Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer
Landauer
Category
Medical Device — Radiation Monitoring / Dosimetry
Hazard
  • dosimeter-measurement-inaccuracy
  • material-non-conformance
  • radiation-safety-risk

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.

Related recalls

Same category