Events

Recall of Device Recall Human Fetal Hemoglobin (HBF1) FITC Conjugate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Life Technologies Corporation.

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
    79603
  • Event Risk Class
    Class 2
  • Event Number
    Z-1388-2018
  • Event Initiated Date
    2018-02-07
  • 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=162776
  • 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
    Stain, fetal hemoglobin - Product Code GHQ
  • Reason
    Three lots of human fetal hemoglobin fitc conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.E. false positives).
  • Action
    All consignees which have purchased the Human Fetal Hemoglobin FITC antibody including facilities/customers that have shipped the lots outside of their facility will be notified via certified mail to check inventory to see if affected product is on hand. Consignees instructed to discontinue use and discard per internal procedure. The effectiveness check will begin 10 days after the distribution date of the Medical Device Recall Notification. The field removal is considered effective when 10% of the affected customers acknowledge receipt and understanding of the notification instructions.

Device

Device Recall Human Fetal Hemoglobin (HBF1) FITC Conjugate
  • Model / Serial
    Model # MHFH01 UDI (01)10190302005579(17)180430 (10)1626670D(240)MHFH01  Lot# 1626670D  Model # MHFH01 UDI (01)10190302005579(17)190830 (10)1873068B(240)MHFH01 Lot# 1873068B  Model # MHFH01 UDI (01)10190302005579(17)191030 (10)1915224B(240)MHFH01  Lot# 1915224B
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA
  • Product Description
    Human Fetal Hemoglobin (HBF-1) FITC Conjugate
  • Manufacturer
    Life Technologies Corporation

Manufacturer

Life Technologies Corporation
  • Manufacturer Address
    Life Technologies Corporation, 7335 Executive Way, Frederick MD 21704-8354
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA