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Beckman Coulter Inc. Recall 87960

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

Beckman Coulter Inc. Recall 87960 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1905-2021
Event ID87960
Event DescriptionAccess SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Product TypeDevices
DistributionUS: 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
Quantity13,337 units
Recall ReasonSARS-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.
Device Classification20210630
Device Code InfoAll Lots
Center Classification Date20210621
Recall Initiation Date20210507
Recalling FirmBeckman Coulter Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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