Events

Recall of ALLSET GOLD SSP HLA CLASS I HIGH RESOLUTION KITS

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
    41514
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-18
  • 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
    A false negative reaction may be observed in the presence of a*11:01:04 specifially for primers pm118c pm118f a11-01 and a11-01a. this could lead to mis-typings during analysis.

Device

ALLSET GOLD SSP HLA CLASS I HIGH RESOLUTION KITS
  • Model / Serial
    Model Catalog: 541100D (Lot serial: Lot 8 Batch 1441210); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1608939); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1608858); Model Catalog: 54310D (Lot serial: Lot 22 Batch 1472871); Model Catalog: 54310D (Lot serial: Lot 22 Batch 63056); Model Catalog: 541100D (Lot serial: Lot 8 Batch 1608856); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1247232); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1293558); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1306794); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1362561); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1395129); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1428078); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1465433); Model Catalog: 54360D (Lot serial: Lot 29 Batch 1508463); Model Catalog: 54360D (Lot serial: Lot 29 Batch 647); Model Catalog: 54360D (Lot serial: Lot 29 Batch 646); Model Catalog: 54360D (Lot serial: Lot 29 Batch 645); Model Catalog: 54360D (Lot serial: Lot 29 Batch 158
  • Product Description
    AllSet Gold SSP HLA Class I High Resolution Kits;AllSet Gold HLA Low Resolution Kits;AllSet Gold ABDRQ Low Resolution Kit;AllSet Gold ABDR Low Resolution Kit;AllSet Gold SSP HLA Direct to High Resolution Kit;AllSet Gold HLA ABC Low - Resolution SSP Kit 10
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC