Events

Recall of Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900

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
    78776
  • Event Risk Class
    Class 2
  • Event Number
    Z-0491-2018
  • Event Initiated Date
    2017-06-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160396
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • Reason
    This recall has been initiated due to a potential malfunction of the photo interrupter (pl). the potential malfunction has been attributed to aging and premature deterioration of the pl collector current.
  • Action
    Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery.

Device

Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900
  • Model / Serial
    All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S. Nationwide - Latin America
  • Product Description
    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. || Product Usage: || The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

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