Home / Recalls / Roche Diagnostics Corporation / Z-1249-2019

Z-1249-2019 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
May 8, 2019
Initiation Date
March 15, 2019
Termination Date
April 23, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
149

Product Description

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 Pattern

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

Code Information

All units may experience this issue.

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