Events

Recall of REAGENT RED BLOOD CELLS ORTHO 0.8% SURGISCREEN

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
    77182
  • Event Risk Class
    III
  • Event Initiated Date
    2011-08-19
  • 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 has received complaints of broken vials during shipment for some ortho blood products. studies show that vial to vial contact during the shipping process is one of the key contributors to this vial breakage.

Device

REAGENT RED BLOOD CELLS ORTHO 0.8% SURGISCREEN
  • Model / Serial
    Model Catalog: 6902316 (Lot serial: VSS399); Model Catalog: 6901939 (Lot serial: DB285A1); Model Catalog: 6901939 (Lot serial: DB286A1); Model Catalog: 6901939 (Lot serial: DB287A); Model Catalog: 711528 (Lot serial: ABB692AX); Model Catalog: 711528 (Lot serial: ABB693AX); Model Catalog: 711228 (Lot serial: BAA588AX); Model Catalog: 711228 (Lot serial: BAA587AX); Model Catalog: 711228 (Lot serial: BAA589AX); Model Catalog: 71901 (Lot serial: 8A694); Model Catalog: 71901 (Lot serial: 8A704); Model Catalog: 719100 (Lot serial: 3SS408); Model Catalog: 719100 (Lot serial: 3SS407); Model Catalog: 719610 (Lot serial: S531); Model Catalog: 719210 (Lot serial: A282); Model Catalog: 711328 (Lot serial: BBB781AX); Model Catalog: 711328 (Lot serial: BBB780AX); Model Catalog: 711328 (Lot serial: BBB779AX); Model Catalog: 6902315 (Lot serial: VS466); Model Catalog: 6902096 (Lot serial: CNF786); Model Catalog: 6902096 (Lot serial: CNF790); Model Catalog: 711328 (Lot serial: BBB778AX)
  • Product Description
    Reagent Red Blood Cells 0.8% SURGISCREEN
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS