Events

Recall of McFarland Standard

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trek Diagnostic Systems.

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
    50129
  • Event Risk Class
    Class 2
  • Event Number
    Z-0669-2009
  • Event Initiated Date
    2008-09-22
  • Event Date Posted
    2009-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74791
  • 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
    in vitro diagnostic - Product Code JTZ
  • Reason
    Incorrect result: the absorbance has changed as the standards have aged; the standards' turbidity has become denser. the recalled lot is now reading 0.15 abs @ 625 nm. trek's internal specification and the manufacturer's (hardy diagnostics) specification is 0.08 - 0.10 abs @625 nm. clsi specifies 0.08 - 0.13 abs @ 625 nm.
  • Action
    On 9/22/2008 TREK Diagnostic sent a recall notification letter to their customers advising them of the problem with the product. They instructed their customers to inventory their stock for any remaining recall lot and immediately destroy.

Device

McFarland Standard
  • Model / Serial
    Model Number: Hardy = MSO5; Lot number 08182; Expiration date: 10/28/08
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA distribution in OH and IL.
  • Product Description
    HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
  • Manufacturer
    Trek Diagnostic Systems

Manufacturer

Trek Diagnostic Systems
  • Manufacturer Address
    Trek Diagnostic Systems, 982 Keynote Cir Ste 6, Cleveland OH 44131-1873
  • Source
    USFDA