Recall of Device Recall Boehringer Mannheim Cholesterol Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, 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
    Enzymatic esterase--oxidase, cholesterol - Product Code CHH
  • Reason
    Possible drug interference when using the trinder reaction method on multiple cobas analyzers. results of trinder tests may be falsely decreased when the tests are run with urine samples (creatinine plus and uric acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs acetaminophen and n-acetylcysteine.
  • Action
    Roche Diagnostics initiated a voluntary recall and the Urgent Medical Device Correction notices were sent via UPS Ground on 05/07/2015 to customers. Customers were notified of the interference and the method sheets and package inserts will be updated with the new interference claims. The firm plans to monitor any non-responding accounts and address those customers with follow-up attempts to distribute recall notices. The firm plans to conduct level B effectiveness checks via fax and phone. Until the new method sheets are available, the Urgent Medical Device Correction serves as the updated labeling. Roche is not requesting return of the affected product. Customers may contact Todd Siesky Corporate Communications Director, Phone: 317.521.3911, Fax: 317.521.4696, E-mail: For technical questions, contact the Customer Support Center at 1-800-428-2336


  • Model / Serial
    Catalog Numbers: 11491458216; 11875540216; 11875523216.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US (nationwide) including PR.
  • Product Description
    Cholesterol CHOD-PAP. || In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
  • Manufacturer


  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source