Roche Diagnostics Corporation Recall: cobas e 801 immunoassay analyzer, cobas 8000 Modular
Roche Diagnostics Corporation Recall: cobas e 801 immunoassay analyzer, cobas 8000 Modular is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Roche Diagnostics Corporation; Product: cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software contr
| Recalling firm | Roche Diagnostics Corporation |
|---|---|
| Product | cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement. |
| Reason for recall | The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA. |
| Recall initiated | 20180403 |
| Recall number | Z-2136-2018 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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