Roche Diagnostics Corporation recalls cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyz…

Recall date

April 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2136-2018

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.