Events

Recall of S-CAL CALIBRATOR KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    55437
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-07
  • 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
    The hemoglobin (hgb) values for the following s-cal kits were incorrectly assigned 0.3 g/dl (3g/l) lower than the actual value: s-cal calibrator kit (1 x 4.2 ml) part # 179310 kit # 1169206f & 1169207f vial lot # 4705. s-cal calibrator kit (2 x 4.2 ml) part # 624519 kit # 1158251f vial lot # 4705. s-cal calibrator kit (1 x 3.3 ml) part # 628026 kit # 2983070f vial lot # 112972830.

Device

S-CAL CALIBRATOR KIT
  • Model / Serial
    Model Catalog: 628026 (Lot serial: VIAL LOT 112972830); Model Catalog: 179310 (Lot serial: KIT LOT 1169206F & 1169207F); Model Catalog: 179310 (Lot serial: VIAL LOT 112972830); Model Catalog: 628026 (Lot serial: KIT LOT 2983070F); Model Catalog: 624519 (Lot serial: KIT LOT 2983070F); Model Catalog: 179310 (Lot serial: KIT LOT 2983070F); Model Catalog: 628026 (Lot serial: KIT LOT 1158251F VIAL LOT 4705); Model Catalog: 624519 (Lot serial: KIT LOT 1158251F VIAL LOT 4705); Model Catalog: 179310 (Lot serial: KIT LOT 1158251F VIAL LOT 4705); Model Catalog: 628026 (Lot serial: VIAL LOT 4705); Model Catalog: 624519 (Lot serial: VIAL LOT 4705); Model Catalog: 179310 (Lot serial: VIAL LOT 4705); Model Catalog: 628026 (Lot serial: KIT LOT 1169206F & 1169207F); Model Catalog: 624519 (Lot serial: KIT LOT 1169206F & 1169207F); Model Catalog: 624519 (Lot serial: VIAL LOT 112972830)
  • Product Description
    COULTER S-CAL CALIBRATOR KIT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.