FDA Medical Device Recalls (openFDA)
Landauer: QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers
- Recall number
- Z-2569-2023
- Recalling firm
- Landauer
- Product
- QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers
- Status
- Completed
- Initiated
- 2023-07-12
- Posted
- 2023-09-12
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 10741 units
- Distribution
- Worldwide
- Lot, serial or model codes
- UDI/DI 0860003399903, all batch numbers
- 510(k) numbers
- ["K192196"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3008426232
- Firm city
- Glenwood
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28