Events

Recall of ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) 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
    19761
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-06
  • 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 determined through an internal investigation that the assays listed do not align with the representative data published in the instructions for use (ifu) for onboard stability calibration frequency and/or interference. the assays that did not meet the obs and the calibration frequency ifu claims are: microalbumin_2 (ualb_2) alanine aminotransferase (altp5p) lithium (lith) alkaline phosphatase (alpamp) alkaline phosphatase (alpdea) magnesium (mg) magnesium concentrated (mg_c) total protein ii (tp) acetaminophen (acet) immunoglobulin g_2 (igg_2) transferrin (trf) total bilirubin (added to customer notification due to typographical error). the assays that did not meet the interference ifu claims are: alanine aminotransferase (alt) ammonia (amm) carbon dioxide liquid (co2_l) gamma-glutamyl transferase (ggt) high sensitivity c-reactive protein (hscrp) inorganic phosphorus (ip) inorganic phosphorus_concentrated (ip_c) lactate (lac) uric acid_concentrated (ua_c) wide range crp (wrcrp) lithium (lith) alkaline phosphatase (alpamp).

Device

ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • Model / Serial
    Model Catalog: 00141230 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02189346 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03039070 (Lot serial: > 10 numbers contact mfg); Model Catalog: 07371282 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03036926 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02193432 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03056927 (Lot serial: > 10 numbers contact mfg); Model Catalog: 04993452 (Lot serial: > 10 numbers contact mfg); Model Catalog: 01803350 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03051194 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02271328 (Lot serial: > 10 numbers contact mfg); Model Catalog: 06837459 (Lot serial: > 10 numbers contact mfg); Model Catalog: (Lot serial: > 10 numbers contact mfg); Model Catalog: 07989138 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03035814 (Lot serial: > 10 numbers contact mfg); Model Catalog: 07498649 (Lot serial: > 10 numbers contact mfg); Model C
  • Product Description
    ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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