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Terminated

Misys Laboratory System versions 5.23 and 5.3

FDA Recall Z-0791-03 · Posted 2003-05-08

Recall StatusTerminated
Product CodeJQP
Date Initiated2003-03-26
Date Terminated2004-04-21
Product Quantity463

Reason for Recall

With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests.

Firm Action

The firm faxed notification on 3/26/2003 along with a response form and a temporary procedural workaround in Product Safety Notice PSN-03-L13.

Root Cause

Other

Distribution Pattern

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