Beckman Coulter Inc. Recall: Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (0
Beckman Coulter Inc. Recall: Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (0 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Beckman Coulter Inc.; Product: Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744; Reason for recall: SARS-CoV-2 lgG II
| Recalling firm | Beckman Coulter Inc. |
|---|---|
| Product | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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 V |
| Recall initiated | 20210507 |
| Recall number | Z-1905-2021 |
| Category | device |
| State | CA |
| Country | United States |
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