Recall of Access Ultrasensitive Insulin Assay Kit

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Insulin Assay in-vitro diagnostic kit - Product Code CFP
  • Reason
    False negative results when used to test serum samples (as compared to plasma samples).
  • Action
    On September 19, 2007, Beckman Coulter mailed to its consignees an Urgent Product Corrective Action Letter informing them that the affected lots of the product were giving false negative results when used to test serum samples (as compared to plasma samples). The letter instructed consignees to discontinue using the affected lots of the product, and to re-test using an EDTA plasma sample if there was any discordance between the results of the serum sample (if it was obtained using an affected lot of the product) as compared with the clinical presentaion of the patient and the results of other diagnostic tests. The letter also instructed consignees to return, within 10 days, the Response Sheet .


  • Model / Serial
    Part Number 33410, Lot Numbers: 714362 (Exp dt. 3/31/09), 716129 (Exp dt. 6/30/09), 718258 (Exp dt. 7/31/09), 519096 (Exp dt. 10/31/07), 521487 (Exp dt. 2/28/08), 616274 (Exp dt. 7/31/08), 617890 (Exp dt. 7/31/08), 617891 (Exp dt. 7/31/08) and 620204 (Exp dt. 12/31/08)
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide: including USA and Canada.
  • Product Description
    Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems. Beckman Coulter, Inc., Chaska, MN 55318.
  • Manufacturer


  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source