CLASS II Device recall · Reported 27 Mar 2024 · FDA Enforcement Report

microStar Reader recalled by Landauer

Landauer is recalling microStar Reader, distributed nationwide in the US. The recall was initiated on 8 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lot/Serial Numbers:

Quantity recalled975 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-1349-2024
FDA event ID: 94043
Recalling firm: Landauer, Glenwood, IL
Classification: Class II
Status: Completed
Recall initiated: 8 Feb 2024
FDA classified: 21 Mar 2024
Reported: 27 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

8 Feb 2024	Recall initiated by company
21 Mar 2024	Classified by FDA	+42 days
27 Mar 2024	Published in enforcement report	+6 days

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

Reason for recall

Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059

Where it was distributed

Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Brazil, Canada, China, France, India, Japan, Jordan, Malaysia, Mexico, Pakistan, Peru, Philippines, Rep of Korea, Singapore, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, Viet Nam.

Nationwide

Questions about this recall

Is microStar Reader recalled?

Yes. Landauer recalled microStar Reader on 8 Feb 2024. The recall is Class II and its status is Completed. Recall number Z-1349-2024.

Why was it recalled?

Which lots are affected?

All Lot/Serial Numbers:

Where was it sold?

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
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
20 Sep 2023Device	CLASS II	Calibrate (unexposed) nanoDot D2DNS recalled by Landauer	Landauer	Other	IL

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