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Terminated

Roche Cobas driver (rchcob6i), analytical laboratory data interface.

FDA Recall Z-0224-2007 · Posted 2006-11-29

Recalling FirmData Innovations, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2006-11-03
Date Terminated2015-06-11
Product Quantity56

Reason for Recall

Software of modular driver may incorrectly report patient results as Quality Control Results

Firm Action

Data Innovations notified users by email listserv and by letter dated 10/25/06.

Root Cause

Software change control

Distribution Pattern

Nationwide and Canada.

Official Source

View FDA Recall →

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

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