FDA-Device2019-05-08Class II
cobas e 801 immunoassay analyzer
Roche Diagnostics Corporation
Hazard
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.
Sold states
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
Affected count
149
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas e 801 immunoassay analyzer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1249-2019Don't want to check this manually?
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