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
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 →- ModerateLandauer microStar Reader dosimetry system discontinued for medical applications
FDA (Devices) · 2024-03-27
- HighLandauer microSTARii reader recalled for measurement inaccuracy
FDA (Devices) · 2024-01-03
- HighLandauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
FDA (Devices) · 2023-09-20
- HighLandauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
FDA (Devices) · 2023-09-20
- HighLandauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
FDA (Devices) · 2023-09-20
Same hazard · accuracy defect
See all →- HighRadiation monitoring dosimeter units recalled for potential accuracy defect
FDA (Devices) · 2023-09-20