Class 3 Device Recall SYNCHRON LX 20 Clinical System

• Date Initiated by Firm: March 15, 2006
• Date Posted: May 25, 2006
• Recall Status: Terminated on April 19, 2012
• Recall Number: Z-0900-06
• Recall Event ID: 35077
• 510(K)Number: K011213
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software Version 4.5; Part Number: A23724 In vitro diagnostic.
• Code Information: Operating Software Version 4.5
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 4300 N Harbor Blvd; Fullerton CA 92835-1091
• For Additional Information Contact: Melina Cimler; 714-961-8916
• Manufacturer Reason for Recall: It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of 'Other' is selected w/operating software version 4.5. Results for these samples could be elevated as much as twice the actual value. The ORDAC feature does function properly w/serum, plasma, urine & CSF.
• FDA Determined Cause: Other
• Action: User Notification: A Product Corrective Action (PCA) letter will be sent the week of MAR 15, 2006 to all Synchron LX20, LX20PRO, LXi 725, and UniCel DxC 600/800 customers to inform them of the limitation for the use of fluid type 'Other' when programmed in combination with automatic or manual ORDAC for a GLUCm test. Customers are requested to implement one of three workarounds described in the PCA. IN PROCESS Stock Control: 1) A STOP SHIP (BRE-06016-1) was placed on all stock in inventory. DONE 2) Current customers of LX and DxC will be informed of the limitation for the use of fluid type 'Other' when programmed in combination with automatic or manual ORDAC for a GLUCm. IN PROCESS 3) New customers will receive reworked new instrument shipments with documentation regarding the use of fluid type 'Other' when programmed in combination with automatic or manual ORDAC for GLUCm. IN PROCESS 4) A Technical Update is being created to notify worldwide services of the PCA. IN PROCESS *Submit initial corrections and removal report. DONE *Under Investigation. IN PROCESS *Failure analysis is ongoing and preventative actions will be determined based on the investigation results. IN PROCESS *In Process. A 75% effectivity is targeted based the class II level of action required per the Beckman Coulter Product Corrective Action Subcommittee review. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided. This check enables us to ensure that users have received the PCA letter. Records will be maintained of each official contact, and may be made available upon request.
• Quantity in Commerce: 1327 (1261 in US & 66 in Canada)
• Distribution: Nationwide, also Canada, France, Germany, Switzerland, UK, Spain, Belgium, Italy, Netherlands, Sweden, Czech Republic and other countries within Europoe, So. Africa, Isreal Kuwait, united Arab Emirates, Mexico, Argentina, Japan, Australia, Hong Kong, China, Taiwan, Korea, Asia, Africa and the Middle East. Note: According to the firm Customer lists for countires outside North America are maintained by regional offices. If necessary, requests can be made to gather the complete lists.
• 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 and Original Applicant = BECKMAN COULTER, INC.