NanoDots QC Set (Unknown) – Accuracy Range Issue (2023)
Potential measurement inaccuracy can compromise radiation monitoring device performance.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN, in carrier sealed in bag; f) BC30110, description: Calibration set, nanoDot; g) BC30141, description: nanoDot QC Set - Cs137 - Sale; h) BC30142, description: nanoDot Calibration set
Lot Codes / Batch Numbers
UDI/DI 0860003399903, all batch numbers
Products Sold
UDI/DI 0860003399903, all batch numbers
A medical device manufacturer is recalling NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, descrip due to LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.
Recommended Action
Per FDA guidance
Landauer disseminated an URGENT - Medical Device Recall notice to its consignees on 07/12/2023 by US mail and email. The notice explained the problem with the devices, potential risk, and requested the following: Discontinue use of the affected products, destroy used products, and return unused products.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026