Device Recall Siemens CLINITEST hCG

  • Model / Serial
    Lot Expiration 028619, 6/8/2012; 028924, 7/5/2012; 029997, 10/7/2012; 030240, 11/6/2012; 030431, 11/24/2012; 030602, 12/8/2012; 030826, 12/24/2012; 030998, 1/11/2013; 031332, 2/4/2013; 031460, 2/19/2013; 031662, 3/6/2013; 031798, 3/20/2013; 031924, 3/30/2013; 032180, 4/28/2013; and 032106, 4/19/2013.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Austria, Germany, Great Britain, Denmark, Norway, Sweden, Poland, Netherlands, Luxembourg, Belgium, Finland, France, Greece, Ireland, Italy, Portugal, Qatar, Saudi Arabia, Slovakia, Slovenia, and Switzerland.
  • Product Description
    Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105). || For in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA