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Terminated

MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).

FDA Recall Z-1234-2014 · Posted 2014-03-19

Recalling FirmMedical Information Technology, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-02-21
Date Terminated2015-11-12
Product Quantity438

Reason for Recall

Potential for erroneous result reporting.

Firm Action

Beginning on February 3, 2014 MEDITECH distributed a notification to Client Server customers who have the Microbiology product in TEST and/or LIVE only for the releases noted in this correction report. This notification was made via e-mailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. The issue will be corrected by CS LAB DTS 12279.

Root Cause

Device Design

Distribution Pattern

Distributed USA (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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