Events

Recall of Device Recall Captia VZV IgG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Clark Laboratories, Inc. (dba,Trinity Biotech USA).

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
    62440
  • Event Risk Class
    Class 3
  • Event Number
    Z-2445-2012
  • Event Initiated Date
    2012-05-29
  • Event Date Posted
    2012-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110577
  • 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
    Antiserum, cf, varicella-zoster - Product Code GQX
  • Reason
    The positive control for the captia varicella-zoster virus (vzv) igg kit has been reported as running high out of its assigned isr range.
  • Action
    Trinity Biotech sent a "PRODUCT RECALL LETTER" dated May 29, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Fax Back Form was included in the letter for customers to complete and return via fax to (716) 488-1990. Customers were instructed to discard any of the affected product. Contact the Trinity Biotech Help Desk at 800-325-3424, option 2 for questions regarding this recall.

Device

Device Recall Captia VZV IgG
  • Model / Serial
    Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
  • Product Description
    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. || For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
  • Manufacturer
    Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Manufacturer

Clark Laboratories, Inc. (dba,Trinity Biotech USA)
  • Manufacturer Address
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Road, Jamestown NY 14701
  • Manufacturer Parent Company (2017)
    Trinity Biotech plc
  • Source
    USFDA