CLASS II Device recall · Reported 3 Jan 2024 · FDA Enforcement Report
microSTARii reader, Medical Dosimetry System recalled by Landauer
Landauer is recalling microSTARii reader, Medical Dosimetry System. The recall was initiated on 15 Nov 2023 and the FDA has classified it as Class II.
Check your package
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-0616-2024
- FDA event ID
- 93524
- Recalling firm
- Landauer, Glenwood, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 15 Nov 2023
- FDA classified
- 22 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Nov 2023 | Recall initiated by company | |
| 22 Dec 2023 | Classified by FDA | +37 days |
| 3 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction of the reader s LED beam profile with the nanoDot dosimeter. The second is debris formation due to drawer actuation, resulting in a change of reader response that may not be detectable unless known dose QCs are being run regularly.
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
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Where it was distributed
US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
Questions about this recall
Why was it recalled?
MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction of the reader s LED beam profile with the nanoDot dosimeter. The second is debris formation due to drawer actuation, resulting in a change of reader response that may not be detectable unless known dose QCs are being run regularly.
Which lots are affected?
All serial numbers.
Where was it sold?
US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
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 26 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 |
|---|---|---|---|---|---|
| Device | CLASS II | microStar Reader recalled by Landauer | Landauer | Device Malfunction | Nationwide |
| Device | CLASS II | NanoDots, Model Numbers: a) BC30023, description: QC Set recalled | Landauer | Packaging Defects | IL |
| Device | CLASS II | nanoDot D2DNN recalled by Landauer | Landauer | Other | IL |
| Device | CLASS II | Calibrate (80 kVp) nanoDot D2DNS recalled by Landauer | Landauer | Other | IL |
| Device | CLASS II | Calibrate (unexposed) nanoDot D2DNS recalled by Landauer | Landauer | Other | IL |
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