Devices

Device Recall Triglycerides

  • Model / Serial
    Catalog Numbers: 04657594190; 20767107322; 05171407190; 20767107322; 11730711216; 11876023216; 11876040216; 11488872216.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US (nationwide) including PR.
  • Product Description
    Triglycerides GPO. || In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event

Manufacturer

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

3 devices with a similar name

Learn more about the data here

Device Recall Triglycerides/ Glycerol Blanked
  • Model / Serial
    Catalog Numbers:11877771216; 11877780190; 11877798190; 05976006190.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US (nationwide) including PR.
  • Product Description
    Triglycerides/Glycerol Blanked. || In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall Triglycerides (TGL)
  • Model / Serial
    Device Listing: D011286 Triglycerides (TGL), Catalog # DF69A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands
  • Product Description
    Dimension Assays: Triglycerides (TGL)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
Device Recall Triglycerides (TRIG)
  • Model / Serial
    Device Listing: D011436 - Triglycerides (TGL), Catalog # DF69A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands
  • Product Description
    Dimension Vista Assays: Triglycerides (TRIG)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.