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 Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) All lot codes Manufacturing Dates: Approximately March 20, 2020…
Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities
May 27, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s. This recommendation is in follow-up to the April 9, 2021, letter in which the FDA recommended a transition…
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis
[Posted 05/26/2021] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed…
Medically Minded Hand Sanitizer– Nationwide Recall Expansion Due to The Presence of Undeclared Methanol
Summary Company Announcement Date: May 20, 2021 FDA Publish Date: May 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Global Sanitizers Brand Name: Brand Name(s) Medically Minded Product Description: Product Description Hand Sanitizer Company Announcement This is to inform you of a product recall involving: Medically Minded…
Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication
Date Issued: May 19, 2021 The U.S. Food and Drug Administration (FDA) is reminding the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination….
Medical Action Industries, Inc. 306 Recalls Medical Convenience Kits for Risk of Fungal (Aspergillus Penicillioides) Contamination
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 Medical Action Industries, Inc. 306 Medical Convenience Kits Kit Models and Lot Numbers: Please see links below. Distribution Dates: December 12, 2019 to March 22, 2021 Devices Recalled…
Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication
Date Issued: May 20, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Capitol Radiology, LLC, doing business as Laurel Radiology Services, located in Laurel, Maryland, on or after June 26, 2018, about possible problems with the quality of their mammograms. Recommendations for Patients If you have had a…
Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration
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 VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System Models and Serial Numbers: See Medical Device Recall Database Entry Distribution Dates: September 21, 2018…
Mammography Problems at Advanced Women Imaging in Guttenberg, NJ
Date Issued: May 21, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Advanced Women Imaging, located in Guttenberg, NJ, on or after March 11, 2020, about possible problems with the quality of their mammograms. Recommendations for Patients If you have had a more recent mammogram at a different…
Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by HAIOU – Letter to Health Care Providers
May 20, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care facility risk managers, procurement staff, and health care providers stop using certain syringes and needles with needle safety devices manufactured by Guangdong Haiou Medical Apparatus Co., LTD. (HAIOU) at this time while FDA continues our evaluation. The FDA received information about quality…