Events

Recall of Device Recall VITROS Chemistry Products FS Calibrator 1

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
    76200
  • Event Risk Class
    Class 3
  • Event Number
    Z-1181-2017
  • Event Initiated Date
    2017-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152503
  • 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
    Calibrator, secondary - Product Code JIT
  • Reason
    The company received a customer complaint for the inability to calibrate vitros chemistry products dldl reagent when using vitros fs calibrator 1, lot 91461 and add (drv 5908). assay data disk (add) drv versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.
  • Action
    Ortho Clinical Diagnostics sent an Important Product Correction Notification letter (Ref. CL2017-002) and ADD DRV 5911dated January 5, 2017, to all affected customers. The letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to install Assay Data Diskette, DRV 5911 or above on their VITROS System. Foreign affiliates were informed by e-mail on January 5, 2017, of the issue and instructed to notify their consignees of the issue and required actions. Customers with questions were instructed to contact Ortho Care Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Device

Device Recall VITROS Chemistry Products FS Calibrator 1
  • Model / Serial
    Lot 91461, Expiry Date 2018-09-19; Affected Assay Data Diskettes (ADD) Release Versions 5904 through 5910
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide and, Puerto Rico) and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
  • Product Description
    VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- Background: VITROS assays must be calibrated prior to use in order to be used to produce assay results. The Assay Data Disk (ADD) contains calibrator assigned values/ calculation data for multiple VITROS Calibrators and Lots. The Data Release Version (DRV) number identifies the version of the ADD. Each time the ADD is updated with new ata, the DRV number increments higher. The DRV with the highest number contains the most || current data. The VITROS 4600 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System are the only VITROS Systems that run the assays that are associated with VITROS Chemistry Products FS Calibrator || 1. VITROS FS Calibrator 1 is required to calibrate VITROS RF, dLDL, hsCRP, AMPH, BARB, BENZ, COCM, CP, ASO, THC, d%A1c assays. || VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, d%A1c, dLDL, hsCRP, PCP, RF and THC Reagents
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA