Recall of Device Recall Enzyme Immunoassay, Vancomycin

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
    Radioimmunoassay, vancomycin - Product Code LEH
  • Reason
    Roche diagnostics operations, inc. has issued a voluntary recall for the online tdm vancomycin assay on the cobas c 311/501/502 analyzers and the modular analytics p module due method sheets that state an incorrect method comparison against the cobas integra 800 analyzer.
  • Action
    Roche sent an Urgent Medical Device Correction letter dated May 26, 2016, to all affected customers via UPS Ground (receipt required) . The letter identified the product the problem and the action needed to be taken by the customer. Customers will be informed to disregard the method comparison data in the package insert and to follow the instructions outlined in UMDC 16-083. Non-responding accounts will be defined as users for which confirmation of receipt of the Urgent Medical Device Correction cannot be obtained. These accounts will be monitored on an ongoing basis and follow-up attempts will be made accordingly. Affected product under Roche control was placed on hold. Affected product will be reworked to add a sticker referring to customers to UMDC 16-083. Roche is not requesting return of the affected product. Any returned product will be managed according to current procedures. The incorrect method comparison will be removed from the method sheets. Updated method sheets will be released at a later time. Customers may contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.


  • Model / Serial
    04491050190  ONLINE TDM Vancomycin 100 tests 05108420190  ONLINE TDM Vancomycin 200 tests 04642490190  Hitachi Vancomycin (Modular P) 04642481190  Hitachi Vancomycin (917, MOD P)
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN,TX, UT, VA, VT, WA, WI, WV, WY Foreign:None VA/DOD: See list below
  • Product Description
    ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) || The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.
  • Manufacturer


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