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Terminated

Merge LIS software.

FDA Recall Z-0399-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2015-03-05
Date Terminated2019-04-12
Product Quantity413 sites potentially have the affected software

Reason for Recall

There is a potential for duplicate container numbers to be created for patients.

Firm Action

The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. If no email address was available, the letters were issued via certified mail. Letters to nonresponders were issued 5/26/2016.

Root Cause

Software design

Distribution Pattern

Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.

Official Source

View FDA Recall →

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

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