Events

Recall of MICRO SSP ALLELE SPECIFIC HLA CLASS I

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

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
    32285
  • Event Risk Class
    III
  • Event Initiated Date
    2013-05-28
  • 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 primer in well 2/8/c is incorrect. as a result the presence of a b*38:07 allele would cause an assignment to b*38:06. these alleles are very rare occurring. the root cause investigations determined an error occurred during manufacturing- employees did not follow standard operating procedure and there is no verification check in the process. no adverse events or product complaints have been received.

Device

MICRO SSP ALLELE SPECIFIC HLA CLASS I
  • Model / Serial
    Model Catalog: SSPR1-16 (Lot serial: Lot 002 batch 003); Model Catalog: SSPR1-16 (Lot serial: Lot 002 batch 002); Model Catalog: SSPR1-16 (Lot serial: Lot 002 batch 001)
  • Product Description
    Micro SSP Allele Specific HLA Class I DNA Typing tray-B*38/39
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC