Events

Recall of Device Recall Streptavidin Alkaline Phosphatase (Ready to Use)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lab Vision 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
    60967
  • Event Risk Class
    Class 2
  • Event Number
    Z-1089-2012
  • Event Initiated Date
    2012-01-11
  • Event Date Posted
    2012-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107004
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Reason
    Firm was notified by vendor that a component in kits was not meeting internal specifications. declination in product performance confirmed by thermo fisher.
  • Action
    Lab Vision Corporation of Thermo Fisher Scientific sent a Product Recall Notification letters dated January 11, 2012 to all affected customers. The letter identified the affected products, reason for recall and necessary actions to be taken. Customers were instructed to examine inventory, discontinue use, destroy any remaining inventory, follow normal procedure to order an alternate lot of the affected products, retain a copy of this letter for their laboratory records, if the affected products were further distributed provide a copy of this letter to them and complete the attached Customer Recall Response Form and return within 5 days. For questions regarding this information, U.S. customers should call Technical Support at 510-771-1595. Customers outside the U.S. should contact their local area Customer Service.

Device

Device Recall Streptavidin Alkaline Phosphatase (Ready to Use)
  • Model / Serial
    Catalog number: TS-060-AP; Lot Number: SAP101207, Exp 6/2012; Lot Number: SAP110216, Exp 2/2013.  Catalog number: TS-125-AP; Lot Number: SAP110106, Exp. 1/2013; Lot Number: SAP110405, Exp 10/2012.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.
  • Product Description
    Streptavidin Alkaline Phosphatase (Ready to Use) || Manufactured by: Lab Vision Corporation || 46360 Fremont Blvd, Fremont, CA 94538 || Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • Manufacturer Address
    Lab Vision Corporation, 46360 Fremont Blvd, Fremont CA 94538-6406
  • Source
    USFDA