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Terminated

Calculator/ Data Processing Module for Clinical Use.

FDA Recall Z-0235-04 · Posted 2003-12-18

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-09-25
Date Terminated2004-09-03
Product Quantity485

Reason for Recall

Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.

Firm Action

Firm has issued notifcation to all affected customers.

Root Cause

Other

Distribution Pattern

US, UK, Ireland, Denmark, Canada, Bermuda, Saudi Arabia and 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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