Events

Recall of Device Recall HSV 1&2 IgM Enzyme Immunoassay Test Kit

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

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
    61577
  • Event Risk Class
    Class 3
  • Event Number
    Z-1520-2012
  • Event Initiated Date
    2012-01-16
  • Event Date Posted
    2012-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108457
  • 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
    Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
  • Reason
    On 01/16/20112 diamedix initiated a recall of is-hsv 1&2 igm test kit, catalog # 720-350, lot 60701, exp. june 30, 2012. the positive control for this lot is out of specification.
  • Action
    Diamedix sent Recall notification letters dated January 16, 2012, to all affected customers by Certified Mail. Consignees were asked to review their inventory and then contact Diamedix to request replacement product. Customers were instructed to call 305-324-2314 with questions. For questions regarding this recall call 305-324-2560.

Device

Device Recall HSV 1&2 IgM Enzyme Immunoassay Test Kit
  • Model / Serial
    Lot # 60701
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico.
  • Product Description
    Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" || The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. || The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • Manufacturer Address
    Diamedix Corporation, 2140 N. Miami Avenue, Miami FL 33127
  • Source
    USFDA