Events

Recall of Device Recall Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method

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

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
    60811
  • Event Risk Class
    Class 2
  • Event Number
    Z-0921-2012
  • Event Initiated Date
    2011-06-27
  • Event Date Posted
    2012-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106524
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Reason
    Homogeneous enzymic homocysteine reagent two part reagent method will not calibrate due to reagent r1 had prematurely decayed.
  • Action
    Catch Inc. sent an "URGENT-PRODUCT RECALL" letter dated 27 June 2011 to one sole customer. The letter described the product, problem, and actions to be taken by the customer. A reply form was attached to the letter for the customer to complete and return via fax at 425-402-8954. Please contact the firm at 425-402-8960 for questions regarding this recall.

Device

Device Recall Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method
  • Model / Serial
    Lot D1101303
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed in PA.
  • Product Description
    Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02. || A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
  • Manufacturer
    Catch Incorporated

Manufacturer

Catch Incorporated
  • Manufacturer Address
    Catch Incorporated, 11822 N Creek Pkwy N Ste 107, Bothell WA 98011-8203
  • Source
    USFDA