Events

Recall of ACQUITY UPLC I-CLASS SM-FTN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WATERS CORPORATION.

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
    18770
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-07
  • 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
    Waters corporation is initiating a voluntary medical device recall on the following instruments: acquity uplc i-class sm-ftn bsm and ch-a because there is a potential that the instrument label has the ref (part number) and sn (serial number) switched.

Device

ACQUITY UPLC I-CLASS SM-FTN
  • Model / Serial
    Model Catalog: 186015046IVD (Lot serial: All lots); Model Catalog: 186015000IVD (Lot serial: All lots); Model Catalog: 186015042IVD (Lot serial: All lots)
  • Product Description
    Acquity UPLC I-Class SM-FTN;Acquity UPLC I-Class BSM;Acquity UPLC I-Class CH-A
  • Manufacturer
    WATERS CORPORATION

Manufacturer

WATERS CORPORATION