Events

Recall of BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMUI)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA MICROSYSTEMS 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
    69955
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-29
  • 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
    These antibodies and probes when used in combination with specified lots of the bond polymer refine detection and novolink polymer detection system may not provide adequate staining when used according to the instructions for use. if the products are used according to their 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. the absence of adequate staining of tissue 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.

Device

BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMUI)
  • Model / Serial
    Model Catalog: PA0210 (Lot serial: all lots); Model Catalog: PB0645 (Lot serial: all lots); Model Catalog: PB0669 (Lot serial: all lots); Model Catalog: PB0785 (Lot serial: all lots); Model Catalog: PA0552 (Lot serial: all lots); Model Catalog: PB0614 (Lot serial: all lots); Model Catalog: PB0809 (Lot serial: all lots); Model Catalog: PB0589 (Lot serial: all lots); Model Catalog: NCL-L-AMACR (Lot serial: all lots)
  • Product Description
    BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMU1)
  • Manufacturer
    LEICA MICROSYSTEMS INC.

Manufacturer

LEICA MICROSYSTEMS INC.