Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0616-2024.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0616-2024.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0616-2024.
Landauer
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Landauer Recall FAQ
Landauer is the subject of a medical devices safety report: Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000. The notice was published on November 15, 2023 by the U.S. Food and Drug Administration (FDA). Approximately 584 units are potentially affected.