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Terminated

Misys Laboratory, GUI version 5.3

FDA Recall Z-0495-03 · Posted 2003-01-30

Recall StatusTerminated
Product CodeJQP
Date Initiated2002-12-20
Date Terminated2004-12-01
Product Quantity465

Reason for Recall

An incorrect collection date and time may be accepted and filed to the patient file.

Firm Action

The firm's recall notice was sent by fax to all customers on Jan. 3, 2003. It communicated a procedural workaround and the availability of product corrections.

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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