Events

Recall of Device Recall APhL HRP IgG & 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
    39412
  • Event Risk Class
    Class 3
  • Event Number
    Z-0034-2008
  • Event Initiated Date
    2006-07-18
  • Event Date Posted
    2007-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55432
  • 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; outer container labeled with incorrect lot number.
  • Action
    Firm sent replacement labels to consignee via FedEx on 07/18/06 with instructions for consignee to change the labels on the kit boxes before shipping kits to end users.

Device

Device Recall APhL HRP IgG & IgM ELISA Kit
  • Model / Serial
    Lot #060425. Lot number on the outer packaging of the received kits was 060308.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to a distributor in Canada.
  • Product Description
    APhL¿ HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
  • Manufacturer
    Louisville Apl Diagnostics Inc

Manufacturer

Louisville Apl Diagnostics Inc
  • Manufacturer Address
    Louisville Apl Diagnostics Inc, 2622 Nasa Pkwy Ste G2, Seabrook TX 77586-3447
  • Source
    USFDA