Manufacturers

Dade Behring, Inc.

4 devices in the database

Device Recall Stratus CS Acute Care Troponin I TestPak
  • Model / Serial
    Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
  • Product Description
    Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
Device Recall EasyLink Informatics System
  • Model / Serial
    Part number 1000034941
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.
  • Product Description
    EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
Dimension Enzymatic Creatinine Flex reagent cartridge
  • Model / Serial
    Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. || The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
Dimension EXL
  • Model / Serial
    Software versions 8.5.1 and 8.5.1SP3.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of AR, CA, CO, IA, ID, IL, IN, LA, MD, MI, MO, MS, NC, NE, OH, OK, PA, SD, TN, TX, VA, and WI.
  • Product Description
    Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. || The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.

One manufacturer with a similar name

Learn more about the data here

Dade Behring, Inc.
  • Manufacturer Address
    Dade Behring, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Source
    USFDA