Events

Recall of IgM ELISA Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Louisville Apl Diagnostics Inc.

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
    38313
  • Event Risk Class
    Class 2
  • Event Number
    Z-1103-2007
  • Event Initiated Date
    2004-08-10
  • Event Date Posted
    2007-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53389
  • 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 MID
  • Reason
    Product mislabeled; conjugate igg placed in bottles labeled as conjugate igm and vice versa.
  • Action
    Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.

Device

IgM ELISA Kit
  • Model / Serial
    Lot #040531.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product distributed to a single direct account in CT.
  • Product Description
    american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE¿ aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.
  • Manufacturer
    Louisville Apl Diagnostics Inc

Manufacturer

Louisville Apl Diagnostics Inc
  • Manufacturer Address
    Louisville Apl Diagnostics Inc, 2622 NASA Parkway, Suite G2, Seabrook TX 77586-3447
  • Source
    USFDA