Focus Diagnostics Laboratory Examination Kits: Class I Recall - Inaccurate Test Results
Inaccurate results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death.
Italiano
Inaccurate results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death.
L'Agenzia Italiana del Farmaco rende disponibili nuove e importanti raccomandazioni sulla valutazione dello status dell’epatite B prima di iniziare il trattamento con pomalidomide.
Product poses significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Air leakage may lead to an air embolism, which could result in serious injury or death.
Relying on this product for notification of low/high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low/high blood sugar.
Embolism of device fragments could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically.
FDA requiring changes to metformin labeling to provide specific recommendations on use in patients with mild to moderate kidney impairment.
DA adding new Warnings and Precautions to the labels of medicines that contain saxagliptin or alogliptin to inform of the potential increased risk of heart failure.
Product found to contain LGD-4033 Ligandrol, an investigational drug not approved for use. The risks of using this product are unknown.
FDA not recommending removal of this device, since the available data do not suggest any decreased benefit.
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