These tests can be dangerous if the parts of the test kit are swallowed or if the liquid solutions touch a person’s skin or eyes.
Certain lots of Celltrion USA’s DiaTrust COVID-19 Ag Rapid Tests are being recalled for a high number of false positives and a longer shelf life than authorized by the FDA
SD Biosensor's STANDARD Q COVID-19 Ag Home Tests are being recalled because they are not authorized, cleared, or approved by the FDA and may give false results.
Celltrion USA’s DiaTrust COVID-19 Ag Rapid Tests are being recalled for a high number of false positives and a longer shelf life than authorized by the FDA
LuSys Laboratories recalled these tests because they do not have an EUA, 510(k), or PMA and therefore cannot be legally marketed and distributed in the U.S.
Renuvion/J-Plasma has not been cleared for Aesthetic Skin Procedures. FDA warns patients & health care providers of potential risks.
ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name “Flowflex SARS-C
There is a risk of the pumps not delivering medication at the programmed rate displayed on the screen, and in some cases may not alarm for upstream occlusions.
Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level. These compounded products were found to be out-of-specification.
This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.
This device is used during an atherectomy to treat patients who have calcified narrowings and blockages in the peripheral arteries.
Tennessee Technical Coatings Corp. is voluntarily recalling all lots of HAND SANITIZER Isopropyl Alcohol Antiseptic 75% to the consumer/user level. FDA analysis has found the product to contain methanol.
Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials. Microscopic and elemental analyses determined t
B. Braun Medical Inc. (B. Braun) is voluntarily recalling five (5) lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level.
The tests in a dark blue box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
These tests have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
The tests in a green and white box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
Regular clinical follow-up and imaging is critical to detect EVAR device and treatment failures.
FDA reminds 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 from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.
Arrow International, LLC is recalling its Arrow-Trerotola Percutaneous Thrombolytic Device due to potential tip damage during use.