Events

Recall of ALLSET GOLD SSP HLA DIRECT TO HIGH RESOLUTION KITS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIFE TECHNOLOGIES CORPORATION.

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
    116538
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-13
  • 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 customer reported that in allset+ gold a high res ssp kit lot 012 1608823 the reactivity for lane 86 was negative for an a*03:20 allele when the labeling indicates the reactivity should be positive. also the a high res ssp unitray kits are affected by this complaint since they contain the same reagents as the allset+ gold a high res ssp kits. the labeling discrepancy may lead to potentially mistyping an a*03:20 allele (population frequency < 0.01%) as an a*03:01.

Device

ALLSET GOLD SSP HLA DIRECT TO HIGH RESOLUTION KITS
  • Model / Serial
    Model Catalog: 54010D (Lot serial: 012 1648453); Model Catalog: 54010D (Lot serial: 012 1615252); Model Catalog: 54010D (Lot serial: 012 1608903); Model Catalog: 54010D (Lot serial: 012 1395079); Model Catalog: 54010D (Lot serial: 012 1544269); Model Catalog: 54010D (Lot serial: 012 1446993); Model Catalog: 54010D (Lot serial: 012 1608823); Model Catalog: 47290-10 (Lot serial: 012 1608873); Model Catalog: 47290-10 (Lot serial: 012 1467113); Model Catalog: 47290-10 (Lot serial: 012 1580702)
  • Product Description
    ALLSET GOLD A HIGH RES SSP
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION