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.

26–38 of 38

ModerateFDA (Devices)··2023-09-20
Radiation monitoring dosimeters recalled for potential measurement inaccuracy
Landauer is recalling QC (Cs-137) nanoDot D2DNS radiation dosimeters worldwide because some units may operate outside the specified accuracy range. The recall affects 10,741 units with all batch numbers.
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
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0 states
HighFDA (Devices)··2023-09-20
Medical Device: Radiation Dosimeter Units May Have Inaccurate Readings
Landauer nanoDot D2DXN radiation dosimeters may measure outside the specified +/-5.5% accuracy range due to a potential non-conformance in the optical stimulated luminescence material. Approximately 13,950 units were distributed worldwide.
Product
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot B Radiation Dosimeters Recalled for Measurement Accuracy
Landauer nanoDot B radiation dosimeters may have measurement inaccuracies outside the specified +/-5.5% range, potentially compromising radiation exposure monitoring. 16,820 units worldwide are affected.
Product
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation monitoring dosimeter accuracy issue prompts FDA Class II recall
Landauer is recalling 427 nanoDot radiation monitoring dosimeters that may provide inaccurate radiation exposure readings. Some units may fall outside the specified ±5.5% accuracy range due to a manufacturing issue.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring dosimeter used with the microSTAR readers
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HighFDA (Devices)··2023-09-20
Radiation Monitoring Dosimeter Accuracy Issue Affects nanoDot Devices
Landauer recalled nanoDot C radiation dosimeters due to potential accuracy errors in the optical stimulated luminescence material. Affected units may provide dosimetry readings outside the specified tolerance range of +/-5.5%.
Product
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation monitoring dosimeters recalled for potential measurement inaccuracy
Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters because they may give inaccurate readings. Some units may read outside the acceptable accuracy range.
Product
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 04224-KIT; c) 04224-SET; radiation monitoring dosimeter used with the microSTAR readers
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HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters recalled for measurement inaccuracy
Landauer is recalling QC nanoDot radiation dosimeters worldwide due to potential inaccuracy in radiation dose measurements. Some units may read outside the specified ±5.5% accuracy range.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; radiation monitoring dosimeter used with the microSTAR readers
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HighFDA (Devices)··2023-09-20
Radiation Dosimeter Accuracy Issue Recall for nanoDot D2DNS
Landauer is recalling nanoDot D2DNS radiation dosimeters due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters potentially outside accuracy specifications
Landauer is recalling nanoDot radiation dosimeters due to a potential manufacturing defect in the optical measurement material. Some units may fall outside the specified ±5.5% accuracy range.
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
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0 states
HighFDA (Devices)··2023-09-20
Radiation Dosimeter Recall: nanoDot D2DXN Units May Have Inaccurate Readings
Landauer is recalling nanoDot D2DXN radiation dosimeters worldwide due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Radiation dosimeter may report inaccurate exposure readings
Landauer recalls nanoDot D2DNN radiation dosimeters worldwide due to potential accuracy degradation that may cause incorrect exposure readings.
Product
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-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 measurement accuracy defect
Landauer recalled 5,760 nanoDot D2DNN radiation dosimeter units worldwide due to potential inaccuracy in radiation measurement. Some units may read outside the specified +/-5.5% accuracy range due to a defect in the optical stimulated luminescence material.
Product
nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers
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0 states
HighFDA (Devices)··2023-09-20
Landauer NanoDots radiation dosimeters recalled for potential accuracy defect
Landauer is recalling NanoDots radiation monitoring dosimeters worldwide due to potential accuracy defects. Some units may fall outside the specified +/-5.5% accuracy range.
Product
NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e
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