Events

Safety Alert for BioConcept RESIST-3 O.K.N. K-set

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Coris BioConcept.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-02-15
  • Event Date Posted
    2017-02-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170215a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: coris bioconcept resist-3 o.K.N. k-set medical device manufacturer, coris bioconcept, has issued a field safety notice concerning its resist-3 o.K.N. k-set [product code: sun-1kr5; model (lot number): cassette (1kr5k1618); catalogue number: k-15r5; manufacturing date: 12 dec 2016; expiry date: 17 may 2017]. according to the manufacturer, there is a slight shift between the test lines oxa-48 (o) and kpc (k) of the strip and the labeled inscription on the cassette. both test lines of strip are slightly lower than the letter ‘o’ and ‘k’ labeled on the cassette. the problem has been detected by a collaborative contact during some laboratory tests. there is a potential risk of confusing the kpc line with the oxa-48 line when only the kpc signal is readable after the test. a wrong interpretation could impact the treatment received by the patient. the performance of the test is not altered at all and the affected lot meets the manufacturer’s quality standards. to facilitate interpretation of the result, it is recommended to indicate the position of the kpc green line before starting the test. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 15 february 2017.

Device

BioConcept RESIST-3 O.K.N. K-set
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Coris BioConcept RESIST-3 O.K.N. K-set
  • Manufacturer
    Coris BioConcept

Manufacturer

Coris BioConcept