Events

Recall of CALRETININ ANTIBHODY - LIQUID MONOCLONAL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA BIOSYSTEMS NEWCASTLE LTD..

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
    145575
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-04
  • 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
    Leica biosystems recently became aware that novocastra liquid mouse monoclonal antibody calretinin only performed as expected with specific lots of diluents: - ar9352 (lots slbl4196v slbl8154v slbm1997v slbm3199v) - ar9352-cn (lots slbl8154v slbm1997v) - re7133-ce (lot 6035000) - re7133-cn (lot 6035115) in the event that the product is used with diluents other than those listed it may not provide adequate staining. when used according to the instructions for use with appropriate positive controls the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. in these instances the absence of adequate staining of tisse is likely to result in a delay in obtaining the results of ihc / ish staining and in a worst-case scenario could cause a delay in the diagnosis or classification of a neoplasm. this notice only applies to novocastra liquid mouse monoclonal antibody calretinin.

Device

CALRETININ ANTIBHODY - LIQUID MONOCLONAL
  • Model / Serial
    Model Catalog: NCL-L-CALRET-566 (Lot serial: 6029949); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6029060); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6025204); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6036060); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6035923)
  • Product Description
    NOVOCASTRA LIQUID MOUSE MONOCLONAL ANTIBODY CALRETININ
  • Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD.

Manufacturer

LEICA BIOSYSTEMS NEWCASTLE LTD.
  • Manufacturer Address
    NEWCASTLE UPON TYNE
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    HC