Events

Recall of VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.

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
    32801
  • Event Risk Class
    Class 2
  • Event Number
    Z-1460-05
  • Event Initiated Date
    2005-07-19
  • Event Date Posted
    2005-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40842
  • 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
    Enzyme Immunoassay, Gentamicin - Product Code LCD
  • Reason
    Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
  • Action
    Letters dated 7/19/2005 with instructions to process QC fluid according to the IFU when processing patient samples. When replacement product arrives, instructions are to destroy the remaining inventory of the recalled lots.

Device

VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagno...
  • Model / Serial
    01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped nationwide and to Ortho-Clinical/J&J; affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.
  • Product Description
    VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.
  • 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