Class 2 Device Recall Siemens Dimension(R) Chemistry Wash (RD701)

• Date Initiated by Firm: May 06, 2013
• Date Posted: December 24, 2013
• Recall Status: Terminated on August 27, 2014
• Recall Number: Z-0561-2014
• Recall Event ID: 65131
• 510(K)Number: K963498
• Product Classification: Radioimmunoassay (two-site solid phase), ferritin - Product Code JMG
• Product: Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
• Code Information: Lot numbers RD23031, exp 2013-04-29; RD23111, exp 2013-05-07; RD23241, exp 2013-05-19; RD23311, exp 2013-06-04; and RD23461, exp 2013-06-11
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr Ms 514; PO BOX 6101; Newark DE 19702-2466
• For Additional Information Contact: Customer Support; 800-441-9250
• Manufacturer Reason for Recall: Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l
• FDA Determined Cause: Software design
• Action: Siemens sent an Urgent Medical Device Recall letter dated May 2013 to all affected customers. The letter identified the product and lots, the reason for the field action, the risk to health and the action(s) to be taken. Customers were instructed to discontinue use and discard inventory of the affected product. Siemens will replace any unused inventory of the affected lots at no charge. For questions contact your Siemens Technical Center or your local Siemens technical support representative.
• Quantity in Commerce: 17,719
• Distribution: US Nationwide and OUS.
• 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 = JMG