Events

Recall of DIMENSION VISTA SYSTEM - CREATININE 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
    17285
  • Event Risk Class
    III
  • Event Initiated Date
    2016-06-09
  • 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
    Siemens healthcare diagnostics has confirmed that dimension creatinine (cre2) assay and dimension vista creatinine (cre2) assay exhibits a negative bias at the low end of the urine analytical measurement range (amr). the limit of quantitation (loq) claim (5 mg/dl [442 umol/l]) for urine samples is not met. siemens is actively investigating the root cause of the issue and is working to implement a solution. this issue also affects all future lots of cre2 until a solution is implemented. the serum/plasma cre2 amr is not affected by this issue.

Device

DIMENSION VISTA SYSTEM - CREATININE ASSAY
  • Model / Serial
    Model Catalog: K1033A (Lot serial: ALL LOTS); Model Catalog: 10872082 (Lot serial: ALL LOTS); Model Catalog: 10872079 (Lot serial: ALL LOTS); Model Catalog: DF33B (Lot serial: ALL LOTS)
  • Product Description
    DIMENSION VISTA SYSTEM CREATININE (CRE2) FLEX REAGENT CARTRIDGE;DIMENSION CLINICAL CHEMISTRY SYSTEM CREATININE (CRE2) FLEX REAGENT CARTRIDGE
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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