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Terminated

Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)

FDA Recall Z-0167-2007 · Posted 2006-11-14

Recalling FirmData Innovations, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2006-08-10
Date Terminated2016-02-22
Product Quantity187

Reason for Recall

Patient results may be associated with an incorrect specimen

Firm Action

Data Innovations notified customers by an email listserv notification and by letter dated 8/17/06. A patch would be available on the website to be downloaded.

Root Cause

Other

Distribution Pattern

Worldwide distribution (USA and Canada)

Official Source

View FDA Recall →

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

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