Pregnancy Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Allergy & Food Intolerance Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Ovulation Test (5 tests)
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Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Accriva Diagnostics
Class I - Dangerous
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Food Sensitivity Test Medium
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Class I - Dangerous
Distribution without premarket approval/clearance.
Olympus OER-Pro
Aizu Olympus Co.
Class I - Dangerous
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Men s Hormone Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
H pylori (Peptic ulcer) Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
Class I - Dangerous
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
IntelliVue Patient Monitor MX550. Product Number: 866066.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Neurotransmitters Basic
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Class I - Dangerous
Distribution without premarket approval/clearance.
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Fecal Occult Blood Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX750. Product Number: 866471.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Women s Hormone Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Melatonin Test
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Class I - Dangerous
Distribution without premarket approval/clearance.
Olympus OER-Mini
Aizu Olympus Co.
Class I - Dangerous
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
IntelliVue Patient Monitor MX450. Product Number: 866062.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Neurotransmitters XL
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Class I - Dangerous
Distribution without premarket approval/clearance.