FDA-Device2018-06-20Class II
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.
Roche Diagnostics Corporation
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.
Sold states
US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.
Affected count
35
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2136-2018Don't want to check this manually?
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