Events

Recall of Device Recall ST AIA PACK TT3

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
    34547
  • Event Risk Class
    Class 3
  • Event Number
    Z-0558-06
  • Event Initiated Date
    2006-01-26
  • Event Date Posted
    2006-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44068
  • 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, Total Triiodothyronine - Product Code CDP
  • Reason
    The inner foil packs of aia-pack st tt3, lot fx17440 contain an incorrect expiration date of 10/2005. the outer box is labeled with the correct expiration date of 10/2006.
  • Action
    The recalling firm sent a letter, dated 1/26/06, to all consignees.

Device

Device Recall ST AIA PACK TT3
  • Model / Serial
    Lot #FX17440. The inner foil packs contain an ''incorrect'' expiration date of 10/2005. The outer box is labeled with the ''correct'' expiration date of 10/2006.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    KS, GA, TX, WI
  • Product Description
    TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum. || Each box of product contains 5 trays of 20 test cups per tray. Each tray is packaged in a foil pack. Both the box and foil packs have product labels.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

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