Class 3 Device Recall IMMULITE 2000

• Date Initiated by Firm: April 22, 2005
• Date Posted: July 16, 2005
• Recall Status: Terminated on June 29, 2006
• Recall Number: Z-0994-05
• Recall Event ID: 32010
• 510(K)Number: K970227
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
• Code Information: All analyzers; all serial numbers.
• FEI Number: 1000122204
• Recalling Firm/ Manufacturer: DPC Cirrus; 62 Flanders Bartley Rd; Flanders NJ 07836-4715
• For Additional Information Contact: Alica Salerno; 973-927-2828
• Manufacturer Reason for Recall: The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor.
• FDA Determined Cause: Other
• Action: The firm became aware of the problem on 4/19 and conducted tests on 4/22/05. A service alert for field service engineers and Immulite 2000 distributors was prepared on 4/22/05.
• Quantity in Commerce: There are 941 units in the United States and 3014 units in the international market.
• Distribution: worldwide
• 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.

• 510(K) Database: 510(K)s with Product Code = JJE