Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
🔬
Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Fecal Occult Blood Test
GET TESTED INTERNATIONAL AB
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
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Melatonin Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX450. Product Number: 866062.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
IBS Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Sorbitol Intolerance Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Environmental Pollutants Profile Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Vaginal PH Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Gut Microbiome Test Medium
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Estrogen & Progesterone Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Continuous Glucose Monitor (CGM)
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Class I - Dangerous
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Class I - Dangerous
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Class I - Dangerous
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
BioFire Diagnostics
Class I - Dangerous
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Meridian Bioscience
Class I - Dangerous
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.