Devices

Device Recall AmpliChip CYP450

  • Model / Serial
    US Distribution: Model Number: 4591402190 (US-IVD) Batches: H08499, H10626, H13592, J00807, J00815.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary
  • Product Description
    AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event

Manufacturer

Roche Molecular Systems, Inc.
  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall AmpliChip CYP450
  • Model / Serial
    European Distribution: Model number 4381866190 (CE-IVD) Batches: H08500, H13591, H14242, J00383, J00814
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary
  • Product Description
    AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.
  • Manufacturer
    Roche Molecular Systems, Inc.