Beckman Coulter announced today that it received FDA emergency use authorization (EUA) for its Access SARS-CoV-2 IgG assay. Brea, Calif.-based Beckman Coulter has already shipped its COVID-19 antibody assay to more than 400 hospitals, clinics and diagnostics laboratories in the U.S. and began distribution globally to countries that accept EUA and its recently garnered CE […]
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Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe. Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the […]
Beckman Coulter announced that it received an expanded partnership with BARDA for its expanding COVID-19 medical countermeasure portfolio. BARDA (the Biomedical Advanced Research and Development Authority, part of the U.S. Dept. of Health and Human Services) awarded Beckman Coulter the partnership in collaboration with Dascena, Inc. The collaboration will offer advanced research and development toward […]
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The FDA filed a Warning Letter against Beckman Coulter Inc. (NYSE:BEC) this month, detailing a long list of alleged quality issues surrounding the company’s manufacturing facility.
Based on an investigation of Beckman’s Brea, Calif.-based facility, the watchdog agency found problems with design validation processes, design change processing procedures, personnel training and reporting and execution systems for corrective and preventative actions, among other complaints.
The FDA put a Class I recall on Beckman Coulter Inc.’s (NYSE:BEC) Synchron clinical chemistry analyzer.
The device is a computer-controlled clinical analyzer for determining chemistries in various fluids including blood, urine and cerebrospinal fluid.