Class 2 Device Recall Dimension Integrated Chemistry Systems

• Date Initiated by Firm: November 10, 2015
• Date Posted: December 22, 2015
• Recall Status: Terminated on August 23, 2017
• Recall Number: Z-0461-2016
• Recall Event ID: 72738
• 510(K)Number: K112999
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the available storage of refrigerated Flex reagent cartridges on the Dimension system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex reagent cartridges, allowing the Dimension system to process samples without interruption.
• Code Information: Dimension RXL MAX HM STM Catalog Numbers 752000.941 (Domestic)/752000.951 (Intl). RMS for RxL Catalog Numbers 753000.901 (Domestic)/753000.902 (Intl). All serial numbers.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics Inc.; 101 Silvermine Rd; Brookfield CT 06804-2047
• For Additional Information Contact: 203-740-6404
• Manufacturer Reason for Recall: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Siemens sent an Urgent Medical Device Correction (UMDC # DI-16-01.A.US) and Urgent Field Safety Notice (UFSN # DI-16-01.A.OUS) letters dated November 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. For questions contact your local Siemens technical support representative.
• Quantity in Commerce: 151
• Distribution: US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
• 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