BEUDAMED
    FDA Recall Terminated

    SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software Version 4.5; Part Number: A23724 In vitro diagnostic.

    Recall: Z-0900-06 · Initiated March 15, 2006

    Recall

    Recall Number
    Z-0900-06
    Event Number
    35077
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 15, 2006
    Posted
    May 25, 2006
    Terminated
    April 19, 2012
    Address
    4300 N Harbor Blvd, Fullerton, CA, 92835-1091

    Description

    SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software Version 4.5; Part Number: A23724 In vitro diagnostic.

    Reason

    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.

    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.

    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.

    Quantity

    1327 (1261 in US & 66 in Canada)