Events

Recall of DIMENSION CLINICAL CHEMISTRY SYS. - URINE CFP FLEX TOTAL PROTEIN URINE KSF

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DADE BEHRING CANADA 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
    132449
  • Event Risk Class
    II
  • Event Initiated Date
    2001-03-28
  • 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
    In the ucfp method samples containing amikacin gentamicin kanamycin or tobramycin should be avoided since these substances falsely increase ucfp results.

Device

DIMENSION CLINICAL CHEMISTRY SYS. - URINE CFP FLEX TOTAL PROTEIN URINE KSF
  • Model / Serial
    Model Catalog: DF26 (Lot serial: JC0282 CA0085 LN1340); Model Catalog: DF26 (Lot serial: IS9271 JM1278 JC9299); Model Catalog: DF26 (Lot serial: KP9316 IA0259 IR9251); Model Catalog: DF26 (Lot serial: DA0102 DN1096 KN1312); Model Catalog: DF26 (Lot serial: ZA0343 EQ9149 EB0141); Model Catalog: DF26 (Lot serial: BATCH #S: BM1047 BA0048); Model Catalog: DF26 (Lot serial: LB9364 LC8343 GA0102 GA9202); Model Catalog: DF26 (Lot serial: GA1194 HR1242 SB1124.); Model Catalog: DF26 (Lot serial: FP1159 FB0176 FP9180)
  • Product Description
    URINE CFP FLEX 80 TESTS
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

DADE BEHRING CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC