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Terminated

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

FDA Recall Z-0664-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeOUG
Date Initiated2016-01-30
Date Terminated2019-03-20
Product Quantity324 sites potentially have the affected version

Reason for Recall

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.

Firm Action

The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. Nonresponders were issued a second letter dated 5/25/2016 via email on 5/26/2016.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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