Events

Recall of MONOLISA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories.

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
    44881
  • Event Risk Class
    Class 3
  • Event Number
    Z-0065-2008
  • Event Initiated Date
    2007-09-05
  • Event Date Posted
    2007-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64469
  • 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
    Anti-HBc IGM EIA kit, - Product Code LOM
  • Reason
    Incorrect instruction: the package insert states to add 100l of conjugate; it should state to add 100ul.
  • Action
    On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.

Device

MONOLISA
  • Model / Serial
    Lot 131BHH, Catalog # 26174
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.
  • Product Description
    Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Manufacturer Address
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA