Roche Diagnostics Corporation Recall: cobas e 801 immunoassay analyzer
Roche Diagnostics Corporation Recall: cobas e 801 immunoassay analyzer is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Roche Diagnostics Corporation; Product: cobas e 801 immunoassay analyzer; Reason for recall: The firm has confirmed complaints regarding signal drops on the cobas e 80
| Recalling firm | Roche Diagnostics Corporation |
|---|---|
| Product | cobas e 801 immunoassay analyzer |
| Reason for recall | The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Distributed to accounts in AL AZ CA CT FL HI IA IL IN KY LA MA MD ME MI MN MO NC NH NJ NY OH OR PA PR SC TN TX VA WA WI |
| Recall initiated | 20190315 |
| Recall number | Z-1249-2019 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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