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FDAApril 3, 2018device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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