Events

Recall of VARIANT Sickle Cell Short Program

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
    55905
  • Event Risk Class
    Class 2
  • Event Number
    Z-1846-2011
  • Event Initiated Date
    2010-04-22
  • Event Date Posted
    2011-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92217
  • 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 presence of parameters for version 40400-s on the labeled variant sickle cell short rom card instead of version 80300-s.
  • Action
    The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated April 22, 2010, to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and quarantine the product; complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE FORM via fax to: (510) 741-3954, Attn: Bio-Rad CSD Regulatory Affairs, and contact there regional Bio-Rad office for ROM Card replacement. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.

Device

VARIANT Sickle Cell Short Program
  • Model / Serial
    Catalog number 270-0500, lot numbers 70000349, 70000353, both with expiration dates of 6/30/2011, which contains ROM Card Lot # LA82418 (Catalog # 270-0507). Rom Card is included in kit Lot number 70000349 and 70000353.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore.
  • Product Description
    The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA || The VARIANT Sickle Cell Short Program is designed 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. For in vitro diagnostic use.
  • 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