Events

Recall of VARIANT(tm) nbs Sickle Cell Prograin Reorder Pack.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories 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
    55910
  • Event Risk Class
    Class 3
  • Event Number
    Z-1984-2011
  • Event Initiated Date
    2010-04-14
  • Event Date Posted
    2011-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92218
  • 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
    Abnormal hemoglobin quantitation - Product Code GKA
  • Reason
    The affected resin update cd-roms cause all user-defined settings in the setup/test/data setup sub screen and set/test/pattern setting sub screen to be overwritten when the update kit procedure is performed.
  • Action
    Bio-Rad Laboratories sent out the Urgent Medical Device Correction notice on 4/14/2011, by Federal Express. An Update was sent on May 13th, advising customers of a minor discrepancy in the parameters included on the affected Resin Update CD-ROMs. Customers were instructed to examine your inventory for the affected reorder pack lots. Please complete and return the Medical Device Correction Response Form Questions regarding this recall please call (510) 724-6114.

Device

VARIANT(tm) nbs Sickle Cell Prograin Reorder Pack.
  • Model / Serial
    Resin Update CD-ROM, 250-3020 lot # AA 00092 goes with Reorder Pack Lot No. 50392618 Resin Update CD-ROM, 250-3020 lot # BA 00092 goes with Reorder Pack Lot No 50300210.  Resin Update CD-ROM, 250-3020 lot # CA 00092  Reorder Pack Lot No 50300645 & 50300650. Expiration date: 05/31/2011, 06/30/2011, 08/31/2011 PIN No. 250-3000;
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.
  • Product Description
    VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA