Events

Recall of Device Recall COULTER ACT 5diff Autoloader Hematology Analyzer

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
    58173
  • Event Risk Class
    Class 2
  • Event Number
    Z-1979-2011
  • Event Initiated Date
    2011-02-23
  • Event Date Posted
    2011-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98579
  • 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
    Counter, differential cell - Product Code GKZ
  • Reason
    The recall was initiated because beckman coulter identified a problem with occasional unexpectedly high results for rbc, hct, plt and mpv without instrument generated messages, for the first run of a capped patient sample. upon repeat analysis the results are correct. patients could be affected as described below: (1) false high rbc and hct may result in a delay of treatment, or the delivery of.
  • Action
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTION" letter dated February 23, 2011 with an enclosed customer response form to all customers who have the affected instruments via US Postal Service (in US). The letter described the product, problem and actions to be taken. The customers were instructed not to analyze specimens using the Autoloader. Instead, analyze their samples uncapped (open vial) using the Manual (Stat) Mode. The end of this notice includes a Quick Reference for Running Manual Samples. For more detailed instructions, please refer to your instrument's Instructions for Use (IFU), part number 624026, Section 8.4 Running Manual (Stat) Samples. An electronic version of the IFU can be found in the instrument's On-Line Help screen as well as the Beckman Coulter web site. For inconsistent data during patient's follow-up, please consider unusual/unanticipated high or elevated platelet levels as possible falsely elevated results due to this failure. An appropriate action for the need to look-back at previous results is at the discretion of the Laboratory Director, given the fact that laboratories have a variety of measures that are employed to ensure the validity of the results. Some of these provisions include delta checks, laboratory protocols for validating results and interaction with physicians. Additionally, the customers were also requested to complete and return the enclosed PRODUCT CORRECTION RESPONSE FORM within ten (10) days via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015, or email to: Regulatory.notifications@beckmancoulter.com. For any questions concerning this notice, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter representative.

Device

Device Recall COULTER ACT 5diff Autoloader Hematology Analyzer
  • Model / Serial
    Serial Numbers(s): All Serial Numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Angola Mexico Australia, Azerbaijan, Bangladesh, Bermuda, Botswana, Bulgaria, China, Cote d'Ivoire, Finland, France, Germany, Ghana, Hong Kong, India, Italy, Mexico, Netherlands, New Zealand, Nigeria, Palestinian, Puerto Rico, Romania, Russian Federation,Saudi Arabia, Slovenia, South Africa, Spain, Switzerland,Taiwan, Tanzania, and Turkey.
  • Product Description
    COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial || Numbers(s): All Serial Numbers || The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA