Beckman Coulter Inc. Recall: Access 2 assay Immunoassay System, Remanufactured, Part No. 3
Beckman Coulter Inc. Recall: Access 2 assay Immunoassay System, Remanufactured, Part No. 3 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Beckman Coulter Inc.; Product: Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access
| Recalling firm | Beckman Coulter Inc. |
|---|---|
| Product | Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. |
| Reason for recall | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco |
| Recall initiated | 20170307 |
| Recall number | Z-1710-2017 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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