Events

Recall of VITROS Chemistry Products DT Calibrator Kit

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
    60799
  • Event Risk Class
    Class 2
  • Event Number
    Z-0917-2012
  • Event Initiated Date
    2011-10-13
  • Event Date Posted
    2012-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106492
  • 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, multi-analyte mixture - Product Code JIX
  • Reason
    Ortho clinical diagnostics (ocd) was notified by customers of negatively biased quality control results obtained while using vitros¿ chemistry products nbil dt slides, gen 72. ocd performed an internal investigation and confirmed that negatively biased nbil results could occur for quality control, proficiency and patient samples. as a result, vitros¿ chemistry products dt calibrator kit lots 37 &.
  • Action
    Ortho Clinical Diagnostics (Johnson & Johnson Company) sent an Important Product Correction Notification letter dated October 13, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to recalibrate and instructing them to recalibrate VITROS¿ Chemistry Products NBIL DT Slides, GEN 72 with updated DT calibrator values for the NBIL assay provided on CDM 0164. J&J; Foreign affiliate consignees were notified by e-mail on October 13, 2011, informing them of the issue and of the availability of the updated CDM (0164). Consignees were instructed to complete and return the attached Confirmation of Receipt form upon receipt of the notification even if they do not use VITROS¿ NBIL Slides in their facility. If the affected product was distributed outside the consignees facility they were instructed to forward the notification letter to affected customers. For any questions regarding this recall call 1-800-421-3311.

Device

VITROS Chemistry Products DT Calibrator Kit
  • Model / Serial
    Kit Lot 37 (exp. 3/31/12) and Kit Lot 38 (exp. 3/31/13)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, and Venezuela
  • Product Description
    VITROS¿ Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK || VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
  • 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