Events

Recall of Device Recall Hemoglobin F & A2 Calibrator.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tosoh Bioscience 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
    59488
  • Event Risk Class
    Class 3
  • Event Number
    Z-3030-2011
  • Event Initiated Date
    2011-05-25
  • Event Date Posted
    2011-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102941
  • 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
    Hemoglobin A2 Quantitation - Product Code JPD
  • Reason
    The value after reconstitution appeared to be lower than the assigned value on the label. the measured value for lot bcal05r was 5.3%, whereas the value on the label is 5.7%. the criteria of the value is +/- 0.3%.
  • Action
    TOSOH Bioscience sent an "Urgent Recall Notification" letter dated July, 25, 2011 to all affected customers. The letter described the problem and asks customers to immediately discontinue use of the product and return all remaining product back to the firm. Customers can contact TOSOH for replacement. For additional information or question on this recall please contact TOSOH Technical Support at (800) 248-6769.

Device

Device Recall Hemoglobin F & A2 Calibrator.
  • Model / Serial
    Part Number 020019.  Lot # BCAL05R.  Used By Date 2011-10.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada.
  • Product Description
    Hemoglobin F & A2 Calibrator, || 0.2 mL, 4 brown glass vials/box. || Mfr. By: Tosoh Bioscience, || Minato-ku, Tokyo, Japan. || Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the Tosoh G7.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • Manufacturer Address
    Tosoh Bioscience Inc, 3600 Gantz Road, Grove City OH 43123
  • Source
    USFDA