Events

Recall of SPECIAL STAINS AFB III STAINING KIT

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

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
    89102
  • Event Risk Class
    II
  • Event Initiated Date
    2011-10-22
  • 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
    A staining artefact has been observed on stained slides that may interfere with the interpretation and identification of acid-fast bacteria (afb) which is the indication for this assay. this artefact can be described as circular non-specific purplish-color slide background and the color can vary from blue to pink to purple. the staining artefact has the potential for obstructing visualizagion of acid-fast bactery therefore leading to the potential for false positive or negative results.

Device

SPECIAL STAINS AFB III STAINING KIT
  • Model / Serial
    Model Catalog: 860-027 (Lot serial: E03378); Model Catalog: 860-027 (Lot serial: E01024); Model Catalog: 860-027 (Lot serial: D05755); Model Catalog: 860-027 (Lot serial: D08323); Model Catalog: 860-027 (Lot serial: D11015)
  • Product Description
    AFB III STAINING KIT
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC