Events

Recall of SigmaAldrich Histopaque1077

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sigma-Aldrich Mfg LLC.

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
    53560
  • Event Risk Class
    Class 2
  • Event Number
    Z-0974-2010
  • Event Initiated Date
    2009-09-04
  • Event Date Posted
    2010-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85861
  • 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
    Lymphocyte separation medium - Product Code JCF
  • Reason
    Some of the product was contaminated with pseudomonas mendocina.
  • Action
    An "IMPORTANT PRODUCT NOTIFICATION" dated September 4, 2009 was sent to customers via regular mail. The notification letter described product, problem and action to be taken. The customers were requested to immediately discontinue use of the product and discard all remaining material. Subrecall was requested if the product was further distributed. The customer is to complete and fax the notification form to (314) 286-7829 to assure proper replacement for material they have not used and which is to be discarded. Should you have any questions, please contact Signma-Aldrich Technical Service at (800) 325-5832.

Device

SigmaAldrich Histopaque1077
  • Model / Serial
    Lot #038K6170, Exp. 2011-04
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Great Britain, France, China, Germany, Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong, Peru, Taiwan, and Venezuela.
  • Product Description
    Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. || This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null" lymphocytes.
  • Manufacturer
    Sigma-Aldrich Mfg LLC

Manufacturer

Sigma-Aldrich Mfg LLC
  • Manufacturer Address
    Sigma-Aldrich Mfg LLC, 545 S Ewing Ave, Saint Louis MO 63103-2932
  • Manufacturer Parent Company (2017)
    Merck KGaA
  • Source
    USFDA