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FDAFDA · Food and drugs·Recall number Z-0664-2017

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications

Published December 7, 2016 · Recall initiated: January 30, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Merge Healthcare, Inc.
Distributor
Nationwide Distribution
Lot
Version 1.0
Risk classification
Class II
Area (FDA)
device
Country
United States

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