Devices

Device Recall Advanced DDimer

  • Model / Serial
    Lot numbers 544531 to 544548 and 544502 to 544504.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped nationwide to medical facilities.
  • Product Description
    Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
  • Manufacturer
    Dade Behring , Inc.
  • 1 Event

Manufacturer

Dade Behring , Inc.
  • Manufacturer Address
    Dade Behring , Inc., Rte 896, Glasgow Business Community, Newark DE 19702
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Advanced DDimer
  • Model / Serial
    Catalog number OQWM
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide.
  • Product Description
    Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
  • Manufacturer
    Dade Behring , Inc.