Events

Recall of 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
    38396
  • Event Risk Class
    Class 2
  • Event Number
    Z-1175-2007
  • Event Initiated Date
    2005-10-06
  • Event Date Posted
    2007-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53534
  • 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
    ELISA Kit - Product Code MID
  • Reason
    Mislabeing : errors (control values) identified in the qc fact sheet for a specific lot of aphl hrp igg and igm test kits.
  • Action
    Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.

Device

APhL HRP IgG & IgM ELISA Kit
  • Model / Serial
    Lot #050723
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.
  • Product Description
    APhL¿ HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).
  • 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