nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR re
Summary
The FDA issued a Class II for nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitor by Landauer. Reason: LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDo.
Details
Source
Device Recall
External ID
Z-2556-2023
Action Date
2023-09-20
Status
Completed
Category
device
Product Description
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
Lot/Code Info: UDI/DI 0860003399903, all batch numbers
Quantity Affected: 0
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
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-12
Company
Glenwood, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Landauer has 40 FDA actions in our database, including 40 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Landauer) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Landauer have FDA actions?
Landauer has 40 FDA actions in our database, including 40 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2556-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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