Events

Recall of VITROS Chemistry Products CRP 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
    75692
  • Event Risk Class
    Class 3
  • Event Number
    Z-0864-2017
  • Event Initiated Date
    2016-10-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151060
  • 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
    C-reactive protein, antigen, antiserum, and control - Product Code DCK
  • Reason
    Crp samples diluted using vitros chemistry products specialty diluent, vitros chemistry products fs diluent pack 3, or a sample with a low concentration of crp had positively biased results if the endogenous level of crp in the diluent is not subtracted from the final result. the ifus do not provide specific instructions for how to account for endogenous crp in the diluent when calculating the sample result. orthos diluents used to dilute samples containing crp are manufactured using human plasma based fluids that contain endogenous crp. without accounting for the crp in the diluent and removing its contribution from the result, the reported result will include the crp present in both the sample and diluent, possibly leading to positively biased results.
  • Action
    Ortho Clinical Diagnostics sent an Important Product Correction Notification dated October 26, 2016., via FedEx overnight courier and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who do NOT use ORTHO PLUS e-Communications and received CRP slides within the last 12 months to inform them of the possibility of positively biased CRP results when using VITROS CRP Slides with diluted samples and to provide them with original instructions for how to perform dilutions when processing CRP samples with concentrations above the measuring range. On 1 November 2016, Ortho Clinical Diagnostics issued customer letter (Ref. CL2016-209) sent via ORTHO PLUS e-Communications to all customers who use ORTHO PLUS e-Communications and received CRP slides within the last 12 months to inform them of the possibility of positively biased CRP results when using VITROS CRP Slides with diluted samples and to provide them with two revised instructions on how to perform dilutions when processing CRP samples with concentrations above the measuring range. Foreign affiliates were informed by email on October 26, 2016, of the issue and instructed to notify their consignees of the issue. This included the original instructions for how to perform dilutions when processing CRP samples with concentrations above the measuring range. On 1 November 2016, two revised Instructions for CRP Dilutions enclosures (Ref. CL2016-209) were sent via FedEx overnight courier and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received CL2016-209 via FedEx overnight courier or US Postal Service Priority Mail that provided additional detailed instructions on how to perform a dilution for samples exceeding the measuring range. If you have further questions, please contact our Ortho Care Technical Solutions Center at 1-800-421-3311.

Device

VITROS Chemistry Products CRP Slides
  • Model / Serial
    Affected Generations (GENs): 3, 11, 12, 30 through 36
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Product Description
    VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 513 Technology Blvd, Rochester NY 14626-3601
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA