Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna

[Posted 01/27/2017] AUDIENCE: Consumer ISSUE: FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers…

NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall

[Posted 01/27/2017] AUDIENCE: Laboratory, Patient, Pathology ISSUE: This is a continuation of bioMerieux’s previous recall for NucliSENS easyMAG Magnetic Silica. The firm has identified additional affected product lots, and an additional product, the NucliSENS Magnetic Extraction Reagents, which have been determined to be in scope of the previous recall. bioMerieux is recalling the NucliSENS reagents…

NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Recall

[Posted 01/27/2017] AUDIENCE: Laboratory, Patient, Pathology ISSUE: This is a continuation of bioMerieux’s previous recall for NucliSENS easyMAG Magnetic Silica. The firm has identified additional affected product lots, and an additional product, the NucliSENS Magnetic Extraction Reagents, which have been determined to be in scope of the previous recall. bioMerieux is recalling the NucliSENS reagents…

Class I Medical Device Recall: bioMerieux Recalls NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents due to Potential Inaccurate Test Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents Lot Numbers: See List Below Distribution Dates: May 03, 2016 to August 18. 2016 Devices Recalled in the…

Vancomycin Hydrochloride for Injection, USP by Hospira: Recall

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Mammography Facility Adverse Event and Action Report

BackgroundAs part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In order…

Presentation and Transcript posted for Webinar – Postmarket Management of Cybersecurity in Medical Devices Final Guidance

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