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Beckman Coulter Inc. recalls Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
Recalled June 30, 2021 · FDA recall Z-1906-2021 · Beckman Coulter
Hazard
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values. · FDA Class II
Units
3,843 units
Sold at
US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming, OUS: Andorra, Austria, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, United Arab Emirates
Description
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.
Product
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →