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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Landauer: nanoDot Radiation Dosimeters Recalled for Accuracy Issues

Agency Publication Date: September 12, 2023
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Summary

Landauer is recalling over 1.6 million nanoDot radiation monitoring dosimeters because they may provide readings that are outside the required +/-5.5% accuracy range. This defect is caused by a problem in the material that glows under light to show radiation exposure levels. These devices are used with microSTAR readers to track radiation doses in medical and industrial settings. If the accuracy is compromised, users may receive incorrect data about radiation exposure levels.

Risk

The dosimeters may fail to provide accurate measurements of radiation exposure, potentially leading to an underestimation or overestimation of radiation doses received by patients or staff. While Landauer has received reports of these accuracy issues, no specific injuries have been detailed in the recall data.

What You Should Do

  1. Identify your dosimeter by checking the model number and UDI/DI code 0860003399903 on the product packaging or your purchase records.
  2. Check for affected models including nanoDot D2DNS, D2DNN, D2DXN, D2DXS, and various Calibration or Quality Control (QC) kits such as model numbers 03033-OTO, 03056-1MO, 04293-000, and 18100-000 among many others.
  3. Immediately stop using any dosimeters from the affected batches for critical radiation monitoring tasks.
  4. Contact Landauer directly to verify if your specific batch is affected and to receive instructions on receiving replacement units or corrective actions.
  5. Reach out to your healthcare provider or medical physicist if you have concerns about previous radiation readings obtained using these devices.
  6. For further questions or technical assistance, contact Landauer or call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/replacement

How to: Contact your healthcare provider or the manufacturer (Landauer) for further instructions regarding the accuracy of your dosimeters and potential replacement or refund.

Affected Products

Product: nanoDot D2DNS for custom calibrate, OTO
Model / REF:
03033-OTO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNS for custom calibrate, OTO
Model / REF:
03034-OTO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNN
Model / REF:
03051-1MO
03051-3MO
03051-OTO
03051-SMO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNN
Model / REF:
03053-1MO
03053-1WK
03053-3MO
03053-OTO
03053-SMO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNS
Model / REF:
03055-1MO
03055-3MO
03055-OTO
03055-SMO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNS
Model / REF:
03056-000
VINLNAN002
03056-1MO
03056-3MO
03056-KIT
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNS
Model / REF:
03057-1MO
03057-3MO
03057-OTO
03057-SMO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DXN
Model / REF:
03060-1MO
03060-3MO
03060-OTO
03060-SMO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DXN
Model / REF:
03061-1MO
03061-3MO
03061-OTO
03061-SMO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DXS
Model / REF:
03062-1MO
03062-3MO
03062-OTO
03062-SMO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DXS
Model / REF:
03063-1MO
03063-3MO
03063-OTO
03063-SMO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Calibrate (80 kVp) screened nanoDot D2DNS
Model / REF:
03064-OTO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Calibrate (Cs-137) screened nanoDot D2DNS
Model / REF:
03065-OTO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: QC (80 kVp) screened nanoDot D2DNS
Model / REF:
03066-OTO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: QC (Cs-137) screened nanoDot D2DNS
Model / REF:
03067-OTO
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot kit (contains nanoDot A, B, C)
Model / REF:
03500-000
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot A
Model / REF:
03501-000
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot B
Model / REF:
03502-000
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot C
Model / REF:
03503-000
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Calibrate (80 kVp) nanoDot D2DNS
Model / REF:
04217-000
VINLNAN003
04217-KIT
04217-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: QC (80 kVp) nanoDot D2DNS
Model / REF:
04218-000
VINLNAN004
04218-KIT
04218-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Calibrate (Cs-137) nanoDot D2DNS
Model / REF:
04224-000
VINLNAN006
04224-KIT
04224-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: QC (Cs-137) nanoDot D2DNS
Model / REF:
04225-000
VINLNAN005
04225-KIT
04225-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNN
Model / REF:
04293-000
04293-KIT
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNS
Model / REF:
18100-000
18100-1MO
18100-2MO
18100-KIT
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: nanoDot D2DNN
Model / REF:
18105-000
18105-KIT
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Calibrate (80 kVp) nanoDot D2DNS
Model / REF:
18120-000
18120-KIT
18120-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Calibrate (80 kVp) nanoDot D2DNS
Model / REF:
18121-000
18121-KIT
18121-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Calibrate (Cs-137) nanoDot D2DNS
Model / REF:
18125-000
18125-KIT
18125-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: QC (80 kVp) nanoDot D2DNS
Model / REF:
18130-000
18130-KIT
18130-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: QC (80 kVp) nanoDot D2DNS
Model / REF:
18131-000
18131-KIT
18131-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: QC (Cs-137) nanoDot D2DNS
Model / REF:
18135-000
18135-KIT
18135-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Calibrate (unexposed) nanoDot D2DNS
Model / REF:
18140-000
18140-KIT
18140-SET
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Constancy (80 kVp) nanoDot D2DNN
Model / REF:
18150-000
VKITCON002
18150-KIT
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Constancy (Cs-137) nanoDot D2DNN
Model / REF:
18155-000
VKITCON001
18155-KIT
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: NanoDots QC and Calibration Sets
Model / REF:
BC30023
BC30083
BC30084
BC30088
BC30095
BC30110
BC30141
BC30142
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: NanoDots
Model / REF:
04297-000
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers
Product: Reader, nanoDot adapter, EU
Model / REF:
VINLADA003
UPC Codes:
0860003399903
Lot Numbers:
all batch numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92647
Status: Resolved
Manufacturer: Landauer
Sold By: Landauer; authorized medical device distributors
Manufactured In: United States
Units Affected: 37 products (147 units; 135 units; 5760 units; 35681 units; 60 units; 535643 units; 18638 units; 0; 13950 units; 0; 68007 units; 0; 0; 0; 0; 16760 units; 16820 units; 16820 units; 0; 5958 units; 2240 units; 4005 units; 1440 units; 632928 units; 211815 units; 36805 units; 3947 units; 973 units; 13294 units; 3570 units; 427; 10741 units; 659 units; 512 units; 1880 units; 18333 units; 310 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.