Device Recall TinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive)

  • Model / Serial
    Catalog number: 11972855216, lot number 60445001
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA.
  • Product Description
    Tina-Quant (Latex) HS Test System || (C-Reactive Protein (Latex) High Sensitive) || The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders, and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source