Events

Recall of VITROS Chemistry Products LIPA Slides GEN 48 Coating 3235

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
    36512
  • Event Risk Class
    Class 3
  • Event Number
    Z-0245-2007
  • Event Initiated Date
    2006-10-09
  • Event Date Posted
    2006-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48782
  • 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
    LIPA in vitro diagnostic - Product Code CHI
  • Reason
    The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of vitros¿ lipa slides if they have been stored on the vitros¿ chemistry systems for more than 2 days.
  • Action
    On 10/09/06, Ortho-Clinical Diagnostics sent "IMPORTANT DISTRIBUTOR NOTIFICATION" Letters and "Confirmation of Receipt" Forms via Federal Express to all distributor accounts informing them of the "field correction", and instructing them to inform their customers who received these slides of this issue. OCD foreign affiliates were informed of this action by e-mail on 10/09/06, and instructed them to inform their customers who received the LIPA slides of this "field correction". OCD also sent "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Letters and "Confirmation of Receipt" Forms to US end-user consignees that received the LIPA slides directly from OCD via US Postal Service, informing them of this "field correction" and that they may continue to use their current lot of Coating 3235 LIPA Slides until replacement product arrived providing that they followed the instructions in the letter.

Device

VITROS Chemistry Products LIPA Slides GEN 48 Coating 3235
  • Model / Serial
    Catalog/REF Nos. 166 8409 and 829 7749. All lots.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    VITROS¿ Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS¿ Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA