Events

Recall of Sysmex StromatolyserIM (SIM220A)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sysmex America, 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
    59523
  • Event Risk Class
    Class 2
  • Event Number
    Z-3063-2011
  • Event Initiated Date
    2011-04-11
  • Event Date Posted
    2011-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103015
  • 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
    Products, red-cell lysing products - Product Code GGK
  • Reason
    The affected lots of stromatolyser-im lysing reagent were found to be contaminated with pseudomonas bacteria, which resulted in rising imi channel background counts, increased false "platelet clump" flags and a strong sulfur-like odor when used on the xe-2100, xe-2100l and xe-5000 analyzers.
  • Action
    Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated April 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax to Sysmex Customer Service at 800-689-8296. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the notification are directed to the Sysmex Technical Assistance Center at 1-888-879-7639.

Device

Sysmex StromatolyserIM (SIM220A)
  • Model / Serial
    Catalog number SIM-220A, lot numbers Y0053, Y0054, Y0055
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide and Puerto Rico) and the countries of Canada, Colombia, Ecuador, Mexico, Netherland Antilles and Peru.
  • Product Description
    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. || The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.
  • Manufacturer
    Sysmex America, Inc.

Manufacturer

Sysmex America, Inc.
  • Manufacturer Address
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    USFDA