Summary Company Announcement Date: January 09, 2022 FDA Publish Date: March 11, 2022 Product Type: Medical Devices Counterfeit Reason for Announcement: Recall Reason Description Unauthorized U.S. distribution-counterfeited product Company Name: ACON Laboratories, Inc. Brand Name: Brand Name(s) Flowflex™ Product Description: Product Description SARS-CoV-2 Antigen Rapid Test (Self-Testing) Company Announcement SAN DIEGO, CA, January 9, 2022…
Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification
Summary Company Announcement Date: March 10, 2022 FDA Publish Date: March 10, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Products are out of specification Company Name: Olympia Pharmacy Brand Name: Brand Name(s) Olympia Pharmaceuticals Product Description: Product Description Compounded Injectables Company Announcement Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix…
Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage During Use
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 Product Names: TurboHawk Plus Directional Atherectomy System Product Codes: Manufacturing Dates: July 21, 2021 to November 25, 2021 Distribution Dates: September 27, 2021 to January 25, 2022 …
Tennessee Technical Coatings Corp Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol
Summary Company Announcement Date: March 07, 2022 FDA Publish Date: March 07, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains methanol Company Name: Tennessee Technical Coatings Corp. Brand Name: Brand Name(s) Tennessee Technical Coatings Corp. Product Description: Product Description Hand Sanitizer Company Announcement Tennessee Technical Coatings Corp. is voluntarily recalling all…
Fresenius Kabi Issues Voluntary Recall of Sodium Acetate Injection, USP Due to the Presence of Particulate Matter
Summary Company Announcement Date: March 07, 2022 FDA Publish Date: March 07, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the presence of particulate matter found in reserve and/or stability sample vials Company Name: Fresenius Kabi, USA Brand Name: Brand Name(s) Fresenius Kabi USA Product Description: Product Description Sodium Acetate Injection,…
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 250ML in Excel Due to Fluid Leakage or Low Fill Volume
Summary Company Announcement Date: March 02, 2022 FDA Publish Date: March 03, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Fluid leakage and low fill volume may cause a lack in sterility Company Name: B. Braun Medical Inc. Brand Name: Brand Name(s) B. Braun Medical Inc. Product Description: Product Description 0.9% Sodium Chloride…
Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication
March 2, 2022 Update: The FDA updated this Safety Communication to clarify that the DiaTrust COVID-19 Ag Rapid Tests in the green and white packaging are a product of Celltrion Healthcare. Date Issued: March 1, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use certain Celltrion USA Inc. DiaTrust COVID-19…
Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication
Date Issued: March 1, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test. The test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of…
COVID-19 Test Basics
Image Español 简体中文 한국어 Tagalog Việt COVID-19 testing plays a critical role in the fight against the virus. Understanding COVID-19 tests, including the different types of tests and their uses, and the types of samples the tests use, is key to making an informed decision that meets your needs. Types of Tests There are different…
Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication
Date Issued: March 1, 2021 The U.S. Food and Drug Administration (FDA) is warning people not to use certain ACON Laboratories COVID-19 tests. People should not use the ACON Laboratories test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” that is packaged in a dark blue box (see image below). This test has not been authorized,…