Class 2 Device Recall StreamLab Analytical Workcell

• Date Initiated by Firm: November 12, 2004
• Date Posted: December 28, 2004
• Recall Status: Terminated on March 28, 2005
• Recall Number: Z-0373-05
• Recall Event ID: 30518
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: StreamLab Analytical Workcell. General Purpose Laboratory Device.
• Code Information: Software version 3.5
• Recalling Firm/ Manufacturer: Dade Behring , Inc.; Rte 896, Glasgow Business Community; Newark DE 19702
• For Additional Information Contact: Stanley P. Gorak; 302-631-7456
• Manufacturer Reason for Recall: Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
• FDA Determined Cause: Other
• Action: The recalling firm issued letters dated 11/12/04 to their customers informing them of the problem. The letter also states that a sales representative will contact them to make arrangements for an upgrade.
• Quantity in Commerce: 15 units
• Distribution: The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.
• 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.