Events

Recall of Device Recall BioPlex 2200 Syphilis lgG on the BioPlex 2200 MultiAnalyte

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
    45875
  • Event Risk Class
    Class 2
  • Event Number
    Z-1156-2008
  • Event Initiated Date
    2007-11-13
  • Event Date Posted
    2008-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66382
  • 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
    Syphilis IgG in-vitro diagnostic test kit - Product Code LIP
  • Reason
    False negative results due to reagent packs exhibiting low signal.
  • Action
    On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.

Device

Device Recall BioPlex 2200 Syphilis lgG on the BioPlex 2200 MultiAnalyte
  • Model / Serial
    Lot Numbers: 946314 Exp. 10/31/07, 950630 Exp. 1/31/08 and 946899 Exp. 2/28/08.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
  • Product Description
    BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidium IgG antibodies in human serum.
  • 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