Device Recall PROT 1 CAL

  • Model / Serial
    Lot numbers: 6JC001, 6JC001C, 6JC001G (exp. date 2018-01-11); 6MC001, 6MC001C (exp. date 2018-04-29); 6CC001A, 6CC001B, 6CC001F (exp. date 2017-07-14); 6FC001A, 6FC001C, 6FC001E (exp. 2017-10-27); --- Lot # (UDI): 6CC001A (008427680244436CC001A20170714),  6CC001B (008427680244436CC001B20170714),  6CC001F (008427680244436CC001F20170714),  6FC001A (008427680244436FC001A20171027),  6FC001C (008427680244436FC001C20171027),  6FC001E (008427680244436FC001E20171027),  6JC001 (008427680244436JC00120180111),  6JC001C (008427680244436JC001C20180111),  6JC001G (008427680244436JC001G20180111),  6MC001 (008427680244436MC00120180429),  6MC001C (008427680244436MC001C20180429).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South
  • Product Description
    Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
  • Source
    USFDA