Events

Recall of Device Recall Hemoccult II SENSA elite

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

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
    65980
  • Event Risk Class
    Class 2
  • Event Number
    Z-2197-2013
  • Event Initiated Date
    2013-07-16
  • Event Date Posted
    2013-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121134
  • 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
    The products may have been stored at temperatures outside their required storage conditions.
  • Action
    Independence Medical (im) sent an Urgent Product Recall letter dated July 16, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify and immediately cease the distribution of the recalled products, quarantine the recalled products, and contact the recalling firm at 800-860-8027 for instructions on how to return the recalled products. Consignees who further distributed the recalled products were requested to notify their customers of the recall. Consignees were also instructed to complete the Product Recall Acknowledgement Form and return the document by email to recall@indemed.com indicating receipt of the notification.Customers with questions were instructed to contact the product manufacturer for ProTime Disposable Cuvettes at 800-579-2255, DiaScreen Liquid Urine Controls at 800-818-8877, and Hemoccult II SENSA elite Dispensapak at 800-854-3633. For questions regarding this recall call 800-860-8027.

Device

Device Recall Hemoccult II SENSA elite
  • Model / Serial
    Product Number: 9964130;  Lots: All Lots;  Independence Medical Catalog Number: 9964130
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
  • Product Description
    Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 || The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens.
  • Manufacturer
    Assuramed

Manufacturer

Assuramed
  • Manufacturer Address
    Assuramed, 1810 Summit Commerce Par, K, Twinsburg OH 44087
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA