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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm June 13, 2003
Date Posted August 20, 2003
Recall Status1 Terminated 3 on November 01, 2004
Recall Number Z-1138-03
Recall Event ID 26892
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
Code Information All units.
Recalling Firm/
Manufacturer		 DPC Cirrus
62 Flanders-Bartley Road
Flanders NJ 07836
For Additional Information Contact Alicia Salerno
973-927-2828 Ext. 4521
Manufacturer Reason
for Recall		 Version 2.6 software was released however it will not properly handle adjustment slopes.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 434 upgrades
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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