medical Class II Updated 2021-06-30

Beckman Coulter Inc. recalls Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (

Recalled Product

Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

Hazard / Issue

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.

Issued by

FDA

Distribution: 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
Lot/Code Info: All Lots
View official government recall

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