Class 2 Device Recall Dimension Vista LOCI Reaction Vessel

• Date Initiated by Firm: November 24, 2009
• Date Posted: March 05, 2010
• Recall Status: Terminated on September 08, 2011
• Recall Number: Z-0980-2010
• Recall Event ID: 54039
• 510(K)Number: K051087
• Product Classification: analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Dimension Vista LOCI Reaction Vessel
• Code Information: Catalog number KS855. Lot number NH29-188-09
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 GBC Drive, Mailstop 514; PO BOX 6101; Newark DE 19714-6101
• For Additional Information Contact: Siemens Technical Solutions Center; 800-441-9250
• Manufacturer Reason for Recall: Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued an Urgent Field Safety Notice dated 11/2009 to all affected customers. Customers have been told to discard any bags of the affected lot. If the affected lot is the only lot the customer has, customers can examine a vessel from the bag. If the vessel mold cavity identity is B8, customers should discard the bag. Thus customers can use the lot if the cavity mold is anything other than B8. In addition, customers have been told to empty the LOCI vessel holder on all systems and to discard vessels in case any affected vessels have been loaded onto the system. For technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
• Quantity in Commerce: 408 units
• Distribution: The device was shipped to medical facilities in CA, CO, FL, GA, IL, LA, MD, MI, MS, NE, NC, NJ, NY, OH, SC, TN, TX, VA, WA, and WI. The product was also shipped to Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, and Switzerland.
• 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