Events

Recall of Mouse AntiTTF1 Concentrate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zymed Laboratories 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
    29984
  • Event Risk Class
    Class 2
  • Event Number
    Z-0014-05
  • Event Initiated Date
    2004-04-06
  • Event Date Posted
    2004-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34911
  • 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
    Immunohistochemistry Assay, Antibody, Progesterone Receptor - Product Code MXZ
  • Reason
    Mouse anti-ttf-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
  • Action
    The firm has conducted telephone calls and visits to its consignees, with confirmation done by phone and fax. The firm has recovered or accounted for 100% of the products, either returned or destroyed.

Device

Mouse AntiTTF1 Concentrate
  • Model / Serial
    Product Number 18-0221, no 510(k) number, Product Code MXZ, lot code 40280262.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The Firm distributed to a total of 8 domestic consignees and an unspecified number of foreign consignees. The products were distributed to MD, GA, TX, OH, IL, DC, NY and CA. Foreign countries distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany.
  • Product Description
    Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.
  • Manufacturer
    Zymed Laboratories Inc.

Manufacturer

Zymed Laboratories Inc.
  • Manufacturer Address
    Zymed Laboratories Inc., 561 Eccles Ave, South San Francisco CA 94080-1906
  • Source
    USFDA