Landauer: Medical Device Recall in 2023 - (Recall #: Z-2573-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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 - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers

Product Classification:

Class II

Date Initiated: July 12, 2023

Date Posted: September 20, 2023

Recall Number: Z-2573-2023

Event ID: 92647

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.

Status: Completed

Product Quantity: 18333 units

Code Information:

UDI/DI 0860003399903, all batch numbers

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated