Recall Z-2136-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corporation
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.
| Date | Apr 3, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | On April 3, 2018, The Firm sent an Urgent Medical Device Correction letter via UPS Ground. Consignees were notified of the possible failure. Consignees were informed that a Roche representative would contact them to install a syringe plunger guide for the affected syringes to resolve the issue. In the meantime, consignees were instructed to only measure assays that do not require prewash steps and assays that are not impacted by missing prewash step until the syringe plunger guide is installed on the affected module. If the customer identifies broken syringe plungers on their device, the no |
| Quantity | 35 |
| Distribution | US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA. |
| FDA record | Open on fda.gov |