Home / Recalls / Landauer / Z-2559-2023

Z-2559-2023 Class II

Recalled by Landauer — Glenwood, IL

FDA device recall Z-2559-2023 was initiated by Landauer on July 12, 2023 and is designated Class II. 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-confo… Affected quantity: 4005 units.

Recall Details

Product Type
Devices
Report Date
September 20, 2023
Initiation Date
July 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4005 units

Product Description

Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 04224-KIT; c) 04224-SET; radiation monitoring dosimeter used with the microSTAR readers

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.

Distribution Pattern

Worldwide

Code Information

UDI/DI 0860003399903, all batch numbers

Other recalls by Landauer

  • Z-1349-2024 Class II — microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, (February 8, 2024)
  • Z-0616-2024 Class II — Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000 (November 15, 2023)
  • Z-2565-2023 Class II — Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; (July 12, 2023)
  • Z-2568-2023 Class II — QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) (July 12, 2023)
  • Z-2561-2023 Class II — nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monito (July 12, 2023)
  • Z-2550-2023 Class II — Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation mon (July 12, 2023)
  • Z-2558-2023 Class II — QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN00 (July 12, 2023)
  • Z-2569-2023 Class II — QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) (July 12, 2023)
  • Z-2562-2023 Class II — nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; (July 12, 2023)
  • Z-2552-2023 Class II — QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring (July 12, 2023)

FDA data resources