Events

Recall of Device Recall VITROS Chemistry Products White Reference 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
    67282
  • Event Risk Class
    Class 2
  • Event Number
    Z-1226-2014
  • Event Initiated Date
    2014-01-09
  • Event Date Posted
    2014-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125151
  • 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
    Diazo colorimetry, bilirubin - Product Code CIG
  • Reason
    An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report tbil, bu, bc, and derived tests results. the correct assay value is 0.8658.
  • Action
    Ortho Clinical Diagnostics sent an Urgent Distributor Product Correction Notification letter dated January 9, 2014, via FedEx overnight courier to all affected customers. The letter notified users of the issue and the correct 460 nm value. Foreign affitliates were notified on January 9, 2014 via e-mail. The letter advised users to inspect their current inventory of VITROS White Correction Slides to determine if Lot 9052-0045-6358 is present. If there is remaining inventory of VITROS White correction Slides, Lot 9052-0045-6358, the remaining inventory may be discarded or the user may continue to use the product with the updated 460nm value provided. If VITROS White Correction Slides, Lot 9052-0045-6358 have been previously used to perform the reflectometer correction factors adjustment , then this procedure should be repeated using the corrected 460 nm values or an alternate lot of VITROS White Correction Slides. Customers were instructed to complete and return the Confirmation of Receipt Form and identify all customers and any other branches who were shipped the affected lot from their facility and send a copy of the customer communication. Customers were also instructed to forward the information if they have distributed the affected product outside of their facility. Customers with questions were instructed to call Customer Technical Services. For questions regarding this recall call 908-218-8776.

Device

Device Recall VITROS Chemistry Products White Reference Slides
  • Model / Serial
    Lot 9052-0045-6358, expiry date 01 Aug 2015
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
  • Product Description
    VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. || Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
  • 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