Class 2 Device Recall nanoDot

• Date Initiated by Firm: July 12, 2023
• Date Posted: September 12, 2023
• Recall Status: Completed
• Recall Number: Z-2574-2023
• Recall Event ID: 92647
• 510(K)Number: K192196
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
• Code Information: UDI/DI 0860003399903, all batch numbers
• Recalling Firm/ Manufacturer: Landauer; 2 Science Rd; Glenwood IL 60425-1531
• For Additional Information Contact: Brian Malone; 815-690-1231
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 310 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = IYE