FDA (Devices) recall action 92647

Landauer recalled 38 products on 2023-09-20

The FDA (Devices) publishes a recall like this one as 38 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 38 pages.

Products: 38
Announced: 2023-09-20
Critical: 0
Units: 1,678,258

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 38

HighFDA (Devices)··2023-09-20
Radiation Monitoring Dosimeter Potential Accuracy Error: Worldwide Landauer nanoDot Recall
Landauer is recalling nanoDot D2DXS radiation monitoring dosimeters worldwide due to a potential non-conformance that could cause some units to measure radiation exposure outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeter recalled for potential measurement inaccuracy
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may measure radiation exposure inaccurately, potentially outside the specified +/-5.5% accuracy range. The issue involves the optical stimulated luminescence material used to detect radiation.
Product
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers
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Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.
Product
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.
Product
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.
Product
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot dosimeters recalled for potential accuracy deviation
Landauer has recalled nanoDot radiation dosimeters due to potential accuracy deviations in the Optical Stimulated Luminescence material used to measure radiation exposure. Affected units may read outside the specified +/-5.5% accuracy range.
Product
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
NanoDots radiation dosimeter recalled for potential measurement accuracy issues
Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.
Product
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
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Distribution
0 states
HighFDA (Devices)··2023-09-20
Radiation Dosimeter Kit Recalled Due to Potential Accuracy Drift
Landauer is recalling nanoDot radiation dosimeter kits (16,760 units distributed worldwide) because some units may measure radiation exposure outside specified accuracy tolerances, potentially affecting dose measurement accuracy.
Product
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeter may report inaccurate dose readings
Landauer is recalling certain nanoDot radiation dosimeters worldwide due to a potential flaw in the optical stimulated luminescence material. Affected devices may provide inaccurate radiation dose readings.
Product
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeter units recalled due to accuracy failure
Landauer is recalling 973 radiation dosimeter units that may not accurately measure radiation exposure due to a potential defect in the light-emitting material used for dose measurement.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation monitoring dosimeter units recalled for potential accuracy defect
Landauer is recalling 147 nanoDot D2DNS radiation dosimeters worldwide due to potential non-conformance in the OSL material that may result in readings falling outside the ±5.5% accuracy specification.
Product
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers
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Distribution
0 states
HighFDA (Devices)··2023-09-20
Radiation monitoring dosimeters recalled for potential measurement inaccuracy
Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters worldwide due to a potential material defect that may cause readings to fall outside the specified ±5.5% accuracy range.
Product
Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation Dosimeter May Provide Inaccurate Dose Measurements
Landauer is recalling certain nanoDot D2DNS radiation dosimeters because they may measure radiation exposure outside the specified accuracy range. Approximately 5,958 units worldwide are affected.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers
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0 states
ModerateFDA (Devices)··2023-09-20
Landauer nanoDot Radiation Dosimeter Recall for Accuracy Defect
Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.
Product
nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may read outside the specified ±5.5% accuracy range due to a potential non-conformance in the Optical Stimulated Luminescence material.
Product
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
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Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot Radiation Dosimeter Recalled for Accuracy Defect
Landauer is recalling nanoDot radiation dosimeter adapters (EU Model VINLADA003) worldwide because some units may provide dosimetry readings outside the specified +/-5.5% accuracy range due to a non-conformance in the optical measurement material.
Product
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation monitoring dosimeter recalled for potential measurement inaccuracy
Landauer is recalling Calibrate nanoDot radiation monitoring dosimeters due to a potential defect in the optical luminescence material that may result in inaccurate radiation dose readings.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot D2DNS Radiation Dosimeters Recalled for Accuracy Non-Conformance
Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated luminescence material.
Product
nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNN radiation dosimeters because some units may have measurement accuracy outside their specified +/-5.5% range. Worldwide users should contact the manufacturer to verify device performance.
Product
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation Dosimeter Recall: nanoDot D2DNN Accuracy Outside Specifications
Landauer is recalling nanoDot D2DNN radiation dosimeters worldwide because some units may have measurement accuracy outside the specified +/-5.5% range. Approximately 36,805 units are affected.
Product
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters may be outside accuracy specifications
Landauer is recalling nanoDot D2DNS radiation dosimeters that may be outside the specified +/-5.5% accuracy range. The issue involves a potential non-conformance in the optical measurement material.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers
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Distribution
0 states
ModerateFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters recalled for potential accuracy deviation
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation dosimeter recalled for potential measurement accuracy deviations
Landauer recalled nanoDot D2DNS radiation dosimeters worldwide due to potential inaccuracy in Optical Stimulated Luminescence material. Some units may read outside the specified ±5.5% accuracy range.
Product
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers
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Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer Radiation Dosimeter Recalled for Potential Measurement Inaccuracy
Landauer is recalling 1,880 units of the Constancy nanoDot D2DNN radiation dosimeter due to a potential non-conformance that may cause inaccurate radiation readings. The devices were distributed worldwide.
Product
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation Dosimeter Recall for Potential Measurement Accuracy Issues
Landauer recalls Calibrate nanoDot radiation dosimeters (Model 03064-OTO) worldwide due to potential inaccuracies. Some units may exceed the ±5.5% accuracy specification, resulting in inaccurate radiation exposure readings.
Product
Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers
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Distribution
0 states