FDA recall Z-1249-2019

Roche Diagnostics Corporation · Class II · device

Product

cobas e 801 immunoassay analyzer

Reason for recall

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-03-15
Report date: 2019-05-08
Termination date: 2020-04-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1249-2019