Landauer: Medical Device Recall in 2023 - (Recall #: Z-2558-2023)

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:

QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; 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-2558-2023

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: 2240 units

Code Information:

UDI/DI 0860003399903, all batch numbers

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated