Events

Recall of Device Recall Hemoccult ICT Test Hemoccult ICT (Immunochemical Fecal Occult Blood Test

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
    65832
  • Event Risk Class
    Class 2
  • Event Number
    Z-1997-2013
  • Event Initiated Date
    2013-07-17
  • Event Date Posted
    2013-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120341
  • 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
    Reagent, occult blood - Product Code KHE
  • Reason
    Beckman coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. as a result of our investigation, beckman coulter has confirmed an increase in sensitivity at the borderline positive level. " this testing also demonstrated that the issue does not affect results reported as negative.
  • Action
    Beckman Coulter sent an Urgent Product Correction letter dated July 9, 2013, to all affected customers. The letter was accompanied with a cover letter and response form, dated July 9, 2013. Customers were informed of the product under recall with product description, actions to take, contact information, the issue, impact, and resolution. Beckman Coulter conducted a risk assessment for this issue. Per the risk documentation, there is only a remote probability that use of the product will cause any adverse health consequences,and the product is not likely to lead to serious adverse health consequences. If you have any questions please call (714) 961-3777.

Device

Device Recall Hemoccult ICT Test Hemoccult ICT (Immunochemical Fecal Occult Blood Test
  • Model / Serial
    Part Number 395067.  All In-date lots (42 lots total).  Lot Number: Manuf. Date: Exp. Date: M207143 27Jul2012 01/31/2014 M208454 21Sep2012 02/28/2014 M210079 19Oct2012 03/31/2014 M211100 30Nov2012 05/31/2014 M212122 20Dec2012 06/30/2014 M212203 17Jan2013 06/30/2014 M301418 22Feb2013 & 28Feb2013 07/31/2014 M202086 24Feb2012 07/31/2013 M203081 16Mar2012 07/31/2013 M203081A 23Mar2012 07/31/2013 M203262 06Apr2012 08/31/2013 M203098 13Apr2012 08/31/2013 M203098A 20Apr2012 08/31/2013 M203098B 25Apr2012 08/31/2013 M203080 27Apr2012 10/31/2013 M203080A 04May2012 10/31/2013 M203080B 11May2012 10/31/2013 M204276 18May2012 09/30/2013 M205199 12May2012 09/30/2013 M205288 22May2012 11/30/2013 M206021 06June2012 11/30/2013 M206166 18June2012 12/31/2013 M207072 05July2012 12/31/2013 M207143 27July2012 01/31/2014 M206259 26June2012 12/31/2013 M207332 30July2012 01/31/2014 M208345 22Aug2012 01/31/2014 M208272 24Aug2012 02/28/2014 M208454 06Sep2012 02/28/2014 M209135 19Sep2012 03/31/2014 M210079 04Oct2012 03/31/2014 M210169 27Oct2012 04/30/2014 M211100 10Nov2012 05/31/2014 M211078 01Dec2012 05/31/2014 M212122 12Dec2012 06/30/2014 M212203 03Jan2013 06/30/2014 M301324 16Jan2013 07/31/2014 M301418 11Feb2013 07/31/2014 M302410 27Feb2013 08/31/2014 M303157 15Mar2013 09/30/2014 M303223 26Mar2013 09/30/2014 M304130 09Apr2013 09/30/2014
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the country of Canada.
  • Product Description
    Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA