Recall Z-2566-2023
Landauer · initiated July 12, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; radiation monitoring dosimeter used with the microSTAR readers
Codes / lots: UDI/DI 0860003399903, all batch numbers
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-2566-2023
- Initiated
- July 12, 2023
- Posted by FDA
- September 12, 2023
- Product code
- IYE – Accelerator, Linear, Medical
- Quantity
- 13294 units
- Distribution
- Worldwide
- Recalling firm
- Landauer, Glenwood, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2538-2023 Class II | nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2539-2023 Class II | nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2540-2023 Class II | nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2541-2023 Class II | nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2542-2023 Class II | nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2543-2023 Class II | nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2544-2023 Class II | nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2545-2023 Class II | nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2546-2023 Class II | nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2547-2023 Class II | nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2548-2023 Class II | nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2549-2023 Class II | Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2550-2023 Class II | Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2551-2023 Class II | QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2552-2023 Class II | QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2553-2023 Class II | nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2554-2023 Class II | nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2555-2023 Class II | nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2556-2023 Class II | nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2557-2023 Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2558-2023 Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2559-2023 Class II | Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2560-2023 Class II | QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2561-2023 Class II | nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2562-2023 Class II | nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2563-2023 Class II | nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2564-2023 Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2565-2023 Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2567-2023 Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |
| Z-2568-2023 Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | 07/12/2023Completed |