Recall of Device Recall STAIA PACK FT4

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Radioimmunoassay, free thyroxine - Product Code CEC
  • Reason
    Asfotase alfa (strensiq) interferes with certain tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
  • Action
    The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following: *Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa. " For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology. " Inform all medical professionals that assays utilizing alkaline phosphatase-based technologies must not be used for patients receiving Asfotase Alfa treatment. Continue to use the assays listed in Table 1 for any patients who are not receiving Asfotase Alfa treatment. " Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651, Email: or Regular mail: 3600 Gantz Rd., Grove City, OH 43123. " Maintain this notification with your laboratory records and forward this information to others who may have received this product. " If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: Monday - Friday, from 9:00 AM to 5:00 PM (PST).


  • Model / Serial
    All Lot Codes
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
  • Product Description
    ST-AIA PACK FT4; Part Number: 025268 || Assay, Thyroid
  • Manufacturer


  • Manufacturer Address
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Manufacturer Parent Company (2017)
  • Source