Events

Recall of AFFIRMAGEN 3 REAGENT RED BLOOD CELLS (POOLED CELLS)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL 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
    57862
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-04
  • 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
    Ortho clinical diagnostics (ortho) has initiated this recall because ortho has received an increase in customer complaints and has confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells. ortho conducted an extensive investigation and the root cause for the marked hemolysis has been identified as microbial contamination.

Device

AFFIRMAGEN 3 REAGENT RED BLOOD CELLS (POOLED CELLS)
  • Model / Serial
    Model Catalog: 719211 (Lot serial: 83A291); Model Catalog: 719211 (Lot serial: 83A290); Model Catalog: 719201 (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 719211 (Lot serial: 83A289); Model Catalog: 6902319 (Lot serial: VRC225); Model Catalog: 6902319 (Lot serial: VRC223); Model Catalog: 6902319 (Lot serial: VRC226); Model Catalog: 719810 (Lot serial: > 10 contact manufacturer); Model Catalog: 6902319 (Lot serial: VRC224); Model Catalog: 719100 (Lot serial: > 10 contact manufacturer); Model Catalog: 6902314 (Lot serial: VP226); Model Catalog: 6902314 (Lot serial: VP225); Model Catalog: 6902314 (Lot serial: VP224); Model Catalog: 719520 (Lot serial: RB451); Model Catalog: 719520 (Lot serial: RB458); Model Catalog: 719520 (Lot serial: RB453); Model Catalog: 719520 (Lot serial: RB455); Model Catalog: 719520 (Lot serial: RB456); Model Catalog: 719520 (Lot serial: RB457); Model Catalog: 719520 (Lot serial: RB452); Model Catalog: 6902317 (Lot serial: VRA260); Model Catalog: 6902316 (Lot serial: > 10 con
  • Product Description
    Reagent Red Blood Cells 0.8% AFFIRMAGEN 3;Reagent Red Blood Cells 0.8% AFFIRMAGEN;Reagent Red Blood Cells 0.8% Resolve Panel C System;Reagent Red Blood Cells (Pooled Cells) Ortho Coombs Control;Reagent Red Blood Cells Surgiscreen;Reagent Red Blood Cells O
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS