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Terminated

Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3

FDA Recall Z-0678-03 · Posted 2003-03-26

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-01-17
Date Terminated2004-05-07
Product Quantity520

Reason for Recall

Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.

Firm Action

Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready.

Root Cause

Other

Distribution Pattern

Nationwide and to United Kingdom, Ireland, Canada, Denmark, 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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