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Dade Behring, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
343
FDA recalls
29

What Dade Behring, Inc. makes

Dade Behring, Inc. manufactures diagnostic reagents, calibrators, and testing systems for clinical laboratories, including controls for cholesterol and lipoprotein analysis, coagulation assays, enzymatic calibrators for carbon dioxide measurement, and reagent cartridges for ethanol and triglyceride testing. Their portfolio also covers troponin I and CKMB test kits for acute cardiac care, as well as antimicrobial susceptibility panels for identifying bacterial resistance patterns. Additional offerings include protein standards for research applications and fluorometric analyzers for rapid diagnostic testing.

The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) device classifications, with many authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue343

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FDA recalls29

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 29 recalls initiated by Dade Behring, Inc., the earliest on 2003-04-21 and the most recent on 2008-09-30. By recorded status: 29 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination, packaging, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 29 recalls.

  • 2008

    • 30 Sep 2008 Z-0581-2009 Unclassified (pre-2012) Terminated Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded. 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,…
      Full distribution text 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.
      Submission number: K073604
    • 29 Sep 2008 Z-0485-2009 Unclassified (pre-2012) Terminated Reagent may exhibit unflagged inaccurate patient sample results. Distribution: Nationwide Distribution. Submission number: K073055
    • 23 Jun 2008 Z-0668-2009 Unclassified (pre-2012) Terminated Incorrect result: Potential for false elevation of CTnI results Distribution: Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India. Submission number: K051650

  • 2007

    • 3 Jul 2007 Z-1174-2007 Unclassified (pre-2012) Terminated Sample ID and Patient results could be associated with the wrong patient 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…
      Full distribution text 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.
      Submission number: K051087

  • 2006

    • 27 Sep 2006 Z-0247-2007 Unclassified (pre-2012) Terminated Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing. Distribution: Worldwide, including USA, China, and Germany. Submission number: K820299
    • 3 Apr 2006 Z-0874-06 Unclassified (pre-2012) Terminated Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K003696
    • 3 Apr 2006 Z-0875-06 Unclassified (pre-2012) Terminated Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K984067
    • 3 Apr 2006 Z-0876-06 Unclassified (pre-2012) Terminated Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K033487
    • 3 Apr 2006 Z-0877-06 Unclassified (pre-2012) Terminated Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K051597
    • 3 Apr 2006 Z-0878-06 Unclassified (pre-2012) Terminated Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K984065
Show the 25 most recent of 29 recalls

  • 2006

    • 3 Apr 2006 Z-0879-06 Unclassified (pre-2012) Terminated Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K043476
    • 3 Apr 2006 Z-0880-06 Unclassified (pre-2012) Terminated Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K003696
    • 3 Apr 2006 Z-0881-06 Unclassified (pre-2012) Terminated Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K981099
    • 3 Apr 2006 Z-0882-06 Unclassified (pre-2012) Terminated Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K981098
    • 3 Apr 2006 Z-0883-06 Unclassified (pre-2012) Terminated Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K022976
    • 3 Apr 2006 Z-0884-06 Unclassified (pre-2012) Terminated Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K984065
    • 3 Apr 2006 Z-0885-06 Unclassified (pre-2012) Terminated Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion. Distribution: Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia,…
      Full distribution text Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
      Submission number: K043476

  • 2005

    • 23 Sep 2005 Z-0304-06 Unclassified (pre-2012) Terminated prolonged aPTT results Distribution: The products were shipped to medical facilities and/or laboratories nationwide. Submission number: K811589
    • 29 Jul 2005 Z-0172-06 Unclassified (pre-2012) Terminated Reports of false negative results on Sysmex Coagulation System. Distribution: The product was shipped to medical facilities nationwide. Submission number: K041438
    • 8 Jul 2005 Z-1374-05 Unclassified (pre-2012) Terminated sample may exhibit falsely high results Distribution: The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC,…
      Full distribution text The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC, ND, NV, NY, OH, OK, PA, TX, VA, WA, WI, and WV. The products were also shipped to Germany, Belgium, Switzerland, Sweden, Netherlands, Russia, Spain, France, Italy, Portugal, Australia, Chile, China, Saudi Arabi, Taiwan, and Uraguay.
      Submission number: K924396
    • 21 Jun 2005 Z-1040-05 Unclassified (pre-2012) Terminated positive control shows weak agglutination reaction Distribution: The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland,…
      Full distribution text The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan.
      Submission number: K872360
    • 7 Feb 2005 Z-0668-05 Unclassified (pre-2012) Terminated There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy. Distribution: 71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be…
      Full distribution text 71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be determined at completion of effectiveness check.
      Submission number: P870049

  • 2004

    • 3 Dec 2004 Z-0538-05 Unclassified (pre-2012) Terminated decrease in product stability after reconstitution and reduced stability on board certain instrument systems Distribution: The product was shipped nationwide to medical facilities. Submission number: K041438
    • 12 Nov 2004 Z-0373-05 Unclassified (pre-2012) Terminated Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems. Distribution: The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and…
      Full distribution text The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.
    • 27 Aug 2004 Z-0042-05 Unclassified (pre-2012) Terminated APTT determinations when using affected rotors may lead to incorrectly shortened times Distribution: The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN. Submission number: K011665