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Terminated

Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results

FDA Recall Z-1217-03 · Posted 2003-09-11

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-07-22
Date Terminated2004-06-25
Product Quantity171

Reason for Recall

Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.

Firm Action

Product Safety Notice, PSN-03-L04 was issued to all affected customers by fax on 07/22/2003. This included a procedural workaround to use until a software correction is made available or to use indefinitly at the user''s discretion. Completion of the recall , including release of the software fix is expected in December 2003.

Root Cause

Other

Distribution Pattern

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