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Terminated

Misys Laboratory version 5.3

FDA Recall Z-0686-03 · Posted 2003-04-02

Recall StatusTerminated
Product CodeJQP
Date Initiated2003-02-28
Date Terminated2004-06-02
Product Quantity460

Reason for Recall

Patient results do not update properly when modified using on-line entry function.

Firm Action

Product Safety Notice (PSN-03-L10) was sent to all affected clients by fax on 2/28/2003. It contained a procedural workaround. An announcement of the availability of a software upgrade or fix will be made when it is available.

Root Cause

Other

Distribution Pattern

Nationwide and to United Kingdom, Ireland, Denmark, Canada, Bermuda, Saudi Arabia, United Arab Emirates.

Official Source

View FDA Recall →

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

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