Events

Recall of Device Recall Sensititre MuellerHinton Broth w/Lysed Horse Blood

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
    52813
  • Event Risk Class
    Class 3
  • Event Number
    Z-2324-2009
  • Event Initiated Date
    2009-06-04
  • Event Date Posted
    2009-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84058
  • 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
    Culture Media for Antimicrobial Susceptibility Tests - Product Code JTZ
  • Reason
    Thirty-one boxes of unapproved quarantine product, cp112-10 mhb w/lhb, lot # 150444sa, were inadvertently shipped to customers on 6/2/09 instead of shipping approved lot # 150344sa.
  • Action
    On 6/4/2009 each customer was telephoned and instructed to immediately return the recall lot back to the firm. Replacement product was shipped.

Device

Device Recall Sensititre MuellerHinton Broth w/Lysed Horse Blood
  • Model / Serial
    Lot number 150444SA
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- PA, VA & WA.
  • Product Description
    Sensititre¿ Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA. || In vitro diagnostic products for clinical susceptibility testing of H. influenzae and Streptococcus spp., can provide both qualitative and quantitative results.
  • Manufacturer
    Trek Diagnostic Systems

Manufacturer

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