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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1905-2021 |
| Event ID | 87960 |
| Event Description | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 |
| Product Type | Devices |
| 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 |
| Quantity | 13,337 units |
| Recall Reason | 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. |
| Device Classification | 20210630 |
| Device Code Info | All Lots |
| Center Classification Date | 20210621 |
| Recall Initiation Date | 20210507 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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