Events

Recall of ACL TOP 700

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

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
    23848
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-17
  • 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
    Potential for a sample misidentification on the acl top family that only occurs following a specific set of steps combined with inability of the system to read a specific sample rack barcode.

Device

ACL TOP 700
  • Model / Serial
    Model Catalog: 0000280010 (Lot serial: SN 09080100 to 14050732); Model Catalog: 0000280030 (Lot serial: SN 06020101 to 10080662); Model Catalog: 0000280050 (Lot serial: SN 09120101 to 14050368); Model Catalog: 0000280040 (Lot serial: SN 08010100 to 14052901); Model Catalog: 0000280000 (Lot serial: SN 03110101 to 11111174); Model Catalog: 0000280020 (Lot serial: SN 03110101 to 11111174); Model Catalog: 0000280030 (Lot serial: SN 03110101 to 11111174); Model Catalog: 0000280000 (Lot serial: SN 06020101 to 10080662); Model Catalog: 0000280020 (Lot serial: SN 06020101 to 10080662); Model Catalog: 0000280000 (Lot serial: SN 08120100 to 14050198); Model Catalog: 0000280020 (Lot serial: SN 08120100 to 14050198); Model Catalog: 0000280030 (Lot serial: SN 08120100 to 14050198); Model Catalog: 0000280060 (Lot serial: SN 11110101 to 14051302)
  • Product Description
    ACL TOP 700
  • Manufacturer
    INSTRUMENTATION LABORATORY CO.

Manufacturer

INSTRUMENTATION LABORATORY CO.
  • Manufacturer Address
    BEDFORD
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    HC