Device Recall ADVIA Centaur Cortisol Assay

  • Modèle / numéro de série
    AD VIA Centaur¿ Cortisol reagent kit lots from the reagent lots ending with the following three digits: 254, 255, 256, 257. Kit Lot# 50 Test  70078254 70860254 72058254 73346254 74543254 75397254 76332255 77366255 78595255 79146255 80596255 81274255 82938256 83522256 84771256 86150257 250 Test  69991254 70470254 73049254 74027254 76202255 78071255 80179255 81497255 82689256 83316256 86138257 250 Test  73880254 77890255 80812255 83456256 86151257 Not Applicable . Expiry Date 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 15 Feb 2013 09 May 2013 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 09 May 2013 05 May 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 09 May
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distributed: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRALIA, BANGLADESH, BD, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, EGYPT, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, JAPAN, KOREA, MALAYSIA, MEXICO, NEW ZEALAND, PAKISTAN, PHILIPPINES, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, TAIWAN, THAILAND, URUGUAY, VENEZUELA, and VIETNAM.
  • Description du dispositif
    Siemens ADVIA Centaur Cortisol Assay || Cat. Nos. || 04610138 (1 0321 026)- 250 Test kit || 04610049(10309078)- 50 Test kit || 04611509 (1 0335503)- 250 REF Test kit || ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
  • Source
    USFDA