Events

Recall of Device Recall BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kit

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

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
    64348
  • Event Risk Class
    Class 2
  • Event Number
    Z-0927-2013
  • Event Initiated Date
    2013-02-11
  • Event Date Posted
    2013-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115898
  • 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
    Reagent, borrelia serological reagent - Product Code LSR
  • Reason
    Multiple incidents of low-reacting assay plates.
  • Action
    The firm, Innominata dba GenBio, sent an "Urgent Product Correction" letter dated February 11, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the listed questions to determine sites risk and take the appropriate actions. For questions regarding this issue, customers may contact Bio-Rad Technical Support at : 1-800-224-6723, option #2, and then option #3 for assistance.

Device

Device Recall BIORAD ANTIBORRELIA (LYME) MICROPLATE EIA Kit
  • Model / Serial
    Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
  • Product Description
    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
  • Manufacturer
    Innominata Dba Genbio

Manufacturer

Innominata Dba Genbio
  • Manufacturer Address
    Innominata Dba Genbio, 15222 Avenue Of Science Ste A, San Diego CA 92128-3422
  • Manufacturer Parent Company (2017)
    Innominata
  • Source
    USFDA