Events

Recall of Device Recall UniCel DxC 600/800 SYNCHRON Clinical Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35077
  • Event Risk Class
    Class 3
  • Event Number
    Z-0902-06
  • Event Initiated Date
    2006-03-15
  • Event Date Posted
    2006-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45231
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • 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 versions 1.0 & 1.2. 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.

Device

Device Recall UniCel DxC 600/800 SYNCHRON Clinical Systems
  • Model / Serial
    Software Version 1.0 and 1.2
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and A27331
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 4300 N Harbor Blvd, Fullerton CA 92835-1091
  • Source
    USFDA