NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 8
FDA device recall Z-2573-2023 · posted 2023-09-12 · Completed
Recall details
- Recalling firm
- Landauer
- 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.
- Action taken
- Landauer disseminated an URGENT - Medical Device Recall notice to its consignees on 07/12/2023 by US mail and email. The notice explained the problem with the devices, potential risk, and requested the following: Discontinue use of the affected products, destroy used products, and return unused products.
- Root cause
- Under Investigation by firm
- Status
- Completed
- Product code
- IYE
- Quantity affected
- 18333 units
- Distribution
- Worldwide
- Date initiated
- 2023-07-12
- Date posted
- 2023-09-12
- Location
- Glenwood, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medical Radiation Dosimetry System microSTARii (K192196) | Landauer | 2019-12-27 |