Recall of STREP A TWIST RAPID TEST DEVICE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NOVA CENTURY SCIENTIFIC INC. A DIVISION OF TRINITY BIOTECH PLC..

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
    13126
  • Event Risk Class
    II
  • Event Initiated Date
    2011-09-26
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Through testing it was determined that this product may have an elevated incidence of false positive results. a false positive test result could lead to the administration of antibiotics that are unnecessary. as with all diagnostic tests all results must be interpreted together with other clinical information available to the physician. the root cause is still under investigation.

Device

  • Model / Serial
    Model Catalog: NCS-502T (Lot serial: 9080038); Model Catalog: NCS-502T (Lot serial: 9010062); Model Catalog: NCS-502T (Lot serial: 8100040); Model Catalog: NCS-502T (Lot serial: 8100037); Model Catalog: NCS-502T (Lot serial: 0100050); Model Catalog: NCS-502T (Lot serial: 0060032); Model Catalog: NCS-502T (Lot serial: 0060010); Model Catalog: NCS-502 (Lot serial: 9010101); Model Catalog: NCS-502 (Lot serial: 1010001); Model Catalog: NCS-502 (Lot serial: 9060069); Model Catalog: NCS-502 (Lot serial: 9030135); Model Catalog: NCS-502 (Lot serial: 9030062); Model Catalog: NCS-502 (Lot serial: 0060011); Model Catalog: NCS-502 (Lot serial: 8110066); Model Catalog: NCS-502 (Lot serial: 1070036); Model Catalog: NCS-502 (Lot serial: 1040066); Model Catalog: NCS-502 (Lot serial: 1030052)
  • Product Description
    NCS STREP A TWIST RAPID TEST DEVICE
  • Manufacturer

Manufacturer