Events

Recall of Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. || These are sold under two names as follows: || Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genzyme 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
    28473
  • Event Risk Class
    Class 2
  • Event Number
    Z-0770-04
  • Event Initiated Date
    2004-02-23
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31968
  • 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
    Giardia Spp. - Product Code MHI
  • Reason
    False positive results.
  • Action
    Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.

Device

Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. || These are sold under two names a...
  • Model / Serial
    Lots 081077, 081093, 081138, 071093, 071138.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.
  • Product Description
    Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. || These are sold under two names as follows: || Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay
  • Manufacturer
    Genzyme Diagnostics

Manufacturer

Genzyme Diagnostics
  • Manufacturer Address
    Genzyme Diagnostics, 6659 Top Gun St, San Diego CA 92121-4113
  • Source
    USFDA