Events

Recall of Device Recall VITROS Chemistry Products FS Diluent Pack 3

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
    67883
  • Event Risk Class
    Class 2
  • Event Number
    Z-1520-2014
  • Event Initiated Date
    2014-03-26
  • Event Date Posted
    2014-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126556
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Ortho clinical diagnostics (ocd) confirmed the potential for lower than expected c-reactive protein (crp) results only to be generated when using vitros chemistry products specialty diluent (lot f3168) or vitros chemistry products fs diluent pack 3 (lot 01-3266). the vitros instructions for use states that if the if a c-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with vitros specialty diluent or a patient sample containing a low concentration of crp. an initial threefold dilution is recommended. internal testing determined that results using vitros crp slides have the potential for approximately 51% bias using a 3x dilution factor.
  • Action
    On 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J; Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.

Device

Device Recall VITROS Chemistry Products FS Diluent Pack 3
  • Model / Serial
    Lot 01-3266 (exp. 23-SEPTEMBER-2014)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Product Description
    VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
  • 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