Events

Recall of Device Recall Tosoh ST AIAPACK HbA1c 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
    79708
  • Event Risk Class
    Class 2
  • Event Number
    Z-1810-2018
  • Event Initiated Date
    2018-03-05
  • 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=163122
  • 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
    Calibrator, secondary - Product Code JIT
  • Reason
    The assay can potentially generate erroneously elevated or erroneously decreased hba1c patient results.
  • Action
    On March 5, 2018, the firm notified all customers who have received product since 2011 of the discontinuation of this product from the market. Customers were instructed to immediately discontinue use of all lot numbers of recalled test and components, remove all recalled materials from inventory, and destroy per the customer's local procedures. Customers were also instructed to notify and forward the information to physicians who have received test results provided by recalled products over the past 6 months to determine if follow up testing is required. Customers were advised that the recalling firm is permanently removing all ST AIA-PACK HbA1c test and components from the market, and were instructed to identify an alternative test option for HbA1c. Customers were asked to complete and return the Recall Acknowledgement Form to the recalling firm. Customers may contact Tosoh Technical Support at 1(800)-248-6764, 8AM-5PM PST (voice mail after hours), seven days a week.

Device

Device Recall Tosoh ST AIAPACK HbA1c Calibrator
  • Model / Serial
    All lots.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • Product Description
    Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 || The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
  • 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