Events

Recall of SSP UNITRAY - LOW RESOLUTION CLASS II

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
    61612
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-05
  • 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
    It has been identified that ssp primer mix pmr014g incorrectly identifies the following alleles as having an expected positive reactivity: drb1*11:09/83/87/113 drb1*13:05:01-05:02/06/26:02/42/56/136. therefore the customer would see a false negative according to their documentation in the presence of any of the above listed rare alleles.

Device

SSP UNITRAY - LOW RESOLUTION CLASS II
  • Model / Serial
    Model Catalog: 78401-10 (Lot serial: > 10 numbers contact mfg); Model Catalog: 78400-10 (Lot serial: > 10 numbers contact mfg); Model Catalog: 54380D (Lot serial: 030 1272183); Model Catalog: 54380D (Lot serial: 030 1216651); Model Catalog: 78200-10 (Lot serial: > 10 numbers contact mfg); Model Catalog: 78501-10 (Lot serial: > 10 numbers contact mfg); Model Catalog: 78500-10 (Lot serial: > 10 numbers contact mfg); Model Catalog: 78101-10 (Lot serial: > 10 numbers contact mfg); Model Catalog: 54380D (Lot serial: 031 1312025); Model Catalog: 54360D (Lot serial: 029 1247232); Model Catalog: 54360D (Lot serial: 029 1293558); Model Catalog: 54360D (Lot serial: 029 1306794); Model Catalog: 78100-10 (Lot serial: > 10 numbers contact mfg); Model Catalog: 54380D (Lot serial: 031 1377599); Model Catalog: 54370D (Lot serial: 020 1303555); Model Catalog: 54370D (Lot serial: 020 1205205); Model Catalog: 54350D (Lot serial: 036 1357615); Model Catalog: 54350D (Lot serial: 036 1255129); Model Catalog: 54350D (Lot serial: 0
  • Product Description
    SSP UNITRAY - LOW RESOLUTION CLASS II
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION