Class 2 Device Recall Siemens StreamLAB(R) Analytical Workcell

• Date Initiated by Firm: October 11, 2012
• Date Posted: June 25, 2014
• Recall Status: Terminated on August 26, 2014
• Recall Number: Z-1867-2014
• Recall Event ID: 63486
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
• Code Information: All serial numbers
• FEI Number: 2517506
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 GBC Drive, Mailstop 514; PO BOX 6101; Newark DE 19714-6101
• For Additional Information Contact: 302-631-6311
• Manufacturer Reason for Recall: Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.
• FDA Determined Cause: Device Design
• Action: The firm initiated their recall/correction of this product on October 11, 2012 by sending an Urgent Customer Notification letter to all StreamLAB(R) Automation Solutions customers. The letter informed customers that the firm received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module have contributed to two trip and fall incidents. Customers were advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution. Also, StreamLAB operators were to be notified of the potential safety issue and the notice was to be posted on or near the system. Additionally, customers were to complete and return the attached Field Correction Effectiveness Check form.
• Quantity in Commerce: 317
• Distribution: Nationwide Distribution -- AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
• 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.