Events

Recall of DIMENSION VISTA SYSTEM - PSEUDOCHOLINESTERASE ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    134821
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-14
  • 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
    Increase in frequency of absorbance errors [e141: iod error] on patient samples with the dimension vista pche flex reagent lots: 14147bc 14160ba 14168ab and 14198ac. the [e141: iod error] flag is generated from an iod (initial optical density) test value that is less than the software coded limit of 575. the iod test calculation is used to monitor reagent delivery. reagent that does not produce the typical colour may also generate lower than normal iod test values triggering the [e141: iod error] flag. the issue does not affect every flex and not all well sets. only patient samples with values close to the upper end of the assay range will be impacted and the absorbance error [e141: iod error] flag are not reportable.

Device

DIMENSION VISTA SYSTEM - PSEUDOCHOLINESTERASE ASSAY
  • Model / Serial
    Model Catalog: K3051 (Lot serial: 14198AC); Model Catalog: K3051 (Lot serial: 14168AB); Model Catalog: K3051 (Lot serial: 14160BA); Model Catalog: K3051 (Lot serial: 14147BC)
  • Product Description
    DIMENSION VISTA SYSTEM - PSEUDOCHOLINESTERASE ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC