CLASS II Device recall · Reported 20 Sep 2023 · FDA Enforcement Report

Calibrate (80 kVp) nanoDot D2DNS recalled by Landauer

Landauer is recalling Calibrate (80 kVp) nanoDot D2DNS. The recall was initiated on 12 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 0860003399903, all batch numbers

Quantity recalled3947 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2564-2023
FDA event ID: 92647
Recalling firm: Landauer, Glenwood, IL
Classification: Class II
Status: Completed
Recall initiated: 12 Jul 2023
FDA classified: 12 Sep 2023
Reported: 20 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

12 Jul 2023	Recall initiated by company
12 Sep 2023	Classified by FDA	+62 days
20 Sep 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring dosimeter used with the microSTAR readers

Where it was distributed

Worldwide

Questions about this recall

Is Calibrate (80 kVp) nanoDot D2DNS recalled?

Yes. Landauer recalled Calibrate (80 kVp) nanoDot D2DNS on 12 Jul 2023. The recall is Class II and its status is Completed. Recall number Z-2564-2023.

Why was it recalled?

Which lots are affected?

UDI/DI 0860003399903, all batch numbers

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Landauer

All 40

Reported	Class	Recall	Company	Reason	Where
27 Mar 2024Device	CLASS II	microStar Reader recalled by Landauer	Landauer	Device Malfunction	Nationwide
3 Jan 2024Device	CLASS II	microSTARii reader, Medical Dosimetry System recalled by Landauer	Landauer	Device Malfunction	IL
20 Sep 2023Device	CLASS II	NanoDots, Model Numbers: a) BC30023, description: QC Set recalled	Landauer	Packaging Defects	IL
20 Sep 2023Device	CLASS II	nanoDot D2DNN recalled by Landauer	Landauer	Other	IL
20 Sep 2023Device	CLASS II	Calibrate (80 kVp) nanoDot D2DNS recalled by Landauer	Landauer	Other	IL

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