Events

Recall of Device Recall 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
    58916
  • Event Risk Class
    Class 2
  • Event Number
    Z-2797-2011
  • Event Initiated Date
    2009-06-23
  • Event Date Posted
    2011-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100607
  • 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 was 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 "MEDICAL DEVICE RECALL" letter dated June 2009 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 at 800-218-2711. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the recall letter are directed to the Sysmex Technical Assistance Center at 1-888-879-7639. The firm sent a second notice to non-responding accounts on September 14, 2009. A copy of the June 26, 2009 recall letter and the fax back form were included with the letter. The customers were informed that Sysmex had not received their completed fax back form and were requested to respond to confirm the notification was received.

Device

Device Recall Sysmex StromatolyserIM (SIM220A)
  • Model / Serial
    Catalog number SIM-220A, lot numbers C9010, C9011, C9013, C9014, C9015, C9016 and C9017
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.
  • 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 product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
  • 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