Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
FDA Recall Z-1138-03 · Posted 2003-08-20
Recalling FirmDPC Cirrus
Recall StatusTerminated
Product CodeJJE
Date Initiated2003-06-13
Date Terminated2004-11-01
Product Quantity434 upgrades
Reason for Recall
Version 2.6 software was released however it will not properly handle adjustment slopes.
Firm Action
Recall Technical Bulletins were sent out on 6/13/2003 to all Immulite 2000 users instructing them to not install the provided version 2.6 software.
Root Cause
Other
Distribution Pattern
Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics. Software was also distributed to the firm''s service representatives.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.