Events

Recall of Device Recall Captia (TM) Syphilis IgM Capture

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
    69827
  • Event Risk Class
    Class 3
  • Event Number
    Z-0819-2015
  • Event Initiated Date
    2014-11-17
  • Event Date Posted
    2014-12-16
  • 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=131724
  • 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
    Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
  • Reason
    Through in-house routine real time stability monitoring of trinity's captia syphilis igm capture test kit, lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
  • Action
    Recall notification letters were sent by e-mail to 2 US customers on 11/17/2014 and 11/19/2014. The remaining US customers were sent the letter by FedEx on 11/19/2014. Customers are instructed to discontinue use of any remaining inventory (discard on site if any remain) and provide date of last use (run) and if they obtained valid or invalid runs. Additionally, Trinity is in the process of sending the recall letters to the required EU Regulatory Authorities and the 3 foreign distributors.

Device

Device Recall Captia (TM) Syphilis IgM Capture
  • Model / Serial
    Lot 033, expiry date 30 November 2014
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    New York, Florida, Utah, and California plus foreign distribution to Spain and France
  • Product Description
    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
  • 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 Rd, Jamestown NY 14701-9666
  • Manufacturer Parent Company (2017)
    Trinity Biotech plc
  • Source
    USFDA