Events

Recall of CAPTUS 3000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CAPINTEC 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
    41751
  • Event Risk Class
    II
  • Event Initiated Date
    2006-06-06
  • Event Country
    Canada
  • 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
    Software revision 1.7 contains an error in the bioassay module if used in bq units of measure. this will result in a calculated net bioassay value which is higher than the true bioassay value.

Device

CAPTUS 3000
  • Model / Serial
    Model Catalog: 5430-0106 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0118 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0087 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0077 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0076 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0119 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0118 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0107 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0106 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0103 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0087 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0077 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0076 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0103 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0119 (Lot serial: Upgrade S/N CNV-366 to CNV-374)
  • Product Description
    Captus 3000 Thyroid Uptake System
  • Manufacturer
    CAPINTEC INC.

Manufacturer

CAPINTEC INC.