Events

Recall of Device Recall VITROS Chemistry Products CRBM Slides

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

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
    67788
  • Event Risk Class
    Class 2
  • Event Number
    Z-1470-2014
  • Event Initiated Date
    2014-03-05
  • Event Date Posted
    2014-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126327
  • 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
    Enzyme immunoassay, carbamazepine - Product Code KLT
  • Reason
    The firm identified a potential for biased carbamazepine (crbm) results to be generated when using vitros crbm slides, lot 3920-0080-8403.
  • Action
    The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter (Ref. CL14-086; dated March 5, 2014) via FedEx Overnight Courier and/or US Postal Service Priority Mail (for PO Boxes only) to its US consignees (OCD Direct, Drop-Ship and US Federal Government). In addition, OCD proactively communicated with the 3 affected customers via phone to inform them of the potential issue and expedite product replacement. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue using and discard all remaining inventory of VITROS CRBM Slides, Lot 3920-0800-8403; review previously reported results using this lot; discuss any concerns regarding previously reported results with their Laboratory Medical Director or with the requesting physician; complete the attached Confirmation of Receipt form no later than March 14, 2014; and forward the information in this notification if you have distributed this product outside of your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall VITROS Chemistry Products CRBM Slides
  • Model / Serial
    Lot 3920-0080-8403, expiry date 15-JUNE-2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: IN, MD, and TN.
  • Product Description
    VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA