Events

Recall of MICRO SSP GENERIC HLA CLASS I DNA TYPING TRAYS

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
    26616
  • Event Risk Class
    II
  • Event Initiated Date
    2015-01-12
  • 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
    Allele information on the specific user documents ssp-001b-007-ws-00 revision 0 ssp-abdr-010-ws-00 revision 0 ssp-abdr-010-ws3-00 revision 0 ssp-abdx-010-ws-00 revision 0 ssp-abdx-010-ws3-00 revision 0 ssp-ml02-005-ws-00 revision 0 and ssp-ml02-005-ws3-00 revision 0 (worksheets) is missing and may cause incorrect typing information for analysis completed manually. typing analysis using hla fusion software is not impacted by this issue.

Device

MICRO SSP GENERIC HLA CLASS I DNA TYPING TRAYS
  • Model / Serial
    Model Catalog: SSP1B (Lot serial: SSP1B: 007 BATCH 1-3); Model Catalog: SSPML02 (Lot serial: SSPABDRX: 010 BATCH 1); Model Catalog: SSPABDR (Lot serial: SSPABDR: 010 BATCH 1-5 7-12); Model Catalog: SSPABDRX (Lot serial: SSPABDR: 010 BATCH 1-5 7-12); Model Catalog: SSPML02 (Lot serial: SSPML02: 005 BATCH 1-2); Model Catalog: SSPABDRX (Lot serial: SSPML02: 005 BATCH 1-2); Model Catalog: SSPABDR (Lot serial: SSPML02: 005 BATCH 1-2); Model Catalog: SSPABDRX (Lot serial: SSPABDRX: 010 BATCH 1); Model Catalog: SSPABDR (Lot serial: SSPABDRX: 010 BATCH 1); Model Catalog: SSPML02 (Lot serial: SSPABDR: 010 BATCH 1-5 7-12)
  • Product Description
    MICRO SSP GENERIC HLA CLASS I DNA TYPING TRAYS
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC