Recall Z-1249-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer
| Date | Mar 15, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | On March 15, 2019, the firm notified affected customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the potential problem of signal drops when the standby bottle flowpath is covered with a biofilm. Customers were asked to do the following: " Follow the Workaround section to determine if your cobas e 801 module is potentially affected and perform the steps if applicable. " If your cobas e 801 module is potentially affected based on the information in the Workaround section of this UMDC, contact the Roche Support Network Customer Support Center at |
| Quantity | 149 |
| 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 |
| FDA record | Open on fda.gov |