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Terminated

Calculator/ Data Processing Module for Clinical Use

FDA Recall Z-1220-03 · Posted 2003-09-11

Recall StatusTerminated
Product CodeJQP
Date Initiated2003-07-24
Date Terminated2004-04-23
Product Quantity47

Reason for Recall

Software Design Defect. Under certain conditions, results are removed.

Firm Action

Public Safety Notice was issued to all all affected clients by facsmile on 7/24/2003.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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