Dade Behring, Inc. Recalls

All product recalls associated with Dade Behring, Inc..

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Recall Summary

Total Recalls

18

Past Year

0

Class I (Serious)

0

Most Recent

Sep 2008

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–18 of 18 recalls

Dade Behring, Inc.: Dimension EXL Clinical Chemistry System used with softwar...

Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.

FDASep 30, 2008Nationwide• Dade Behring, Inc.

Dade Behring, Inc.: Dimension Enzymatic Creatinine Flex reagent cartridge, DF...

Reagent may exhibit unflagged inaccurate patient sample results.

FDASep 29, 2008Nationwide• Dade Behring, Inc.

Dade Behring, Inc.: Stratus CS Acute Care Troponin I TestPak, Catalog number ...

Incorrect result: Potential for false elevation of CTnI results

FDAJun 23, 2008Nationwide

• Dade Behring, Inc.

Dade Behring, Inc.: EasyLink Informatics System, software version 3.0, Part N...

Sample ID and Patient results could be associated with the wrong patient

FDAJul 3, 2007AZ, CA, CT +12 more• Dade Behring, Inc.

Dade Behring, Inc.: Dade Behring brand MicroScan Prompt Inoculation System-D;...

Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

FDASep 27, 2006Nationwide• Dade Behring, Inc.

Dade Behring Inc.: Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG...

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.

FDAApr 3, 2006Nationwide• Dade Behring Inc.

Dade Behring Inc.: Dade Actin FS Activated PTT Reagent. Reagent and Control ...

prolonged aPTT results

FDASep 23, 2005Nationwide• Dade Behring Inc.

Dade Behring Inc.: Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, C...

Reports of false negative results on Sysmex Coagulation System.

FDAJul 29, 2005Nationwide• Dade Behring Inc.

Dade Behring Inc.: Coagulation Factor VIII Deficient Plasma (OTXW). Factor D...

sample may exhibit falsely high results

FDAJul 8, 2005AZ, AR, CA +21 more• Dade Behring Inc.

Dade Behring Inc.: Dade Fibrin(ogen) Degradation Products (FDP) Detection Se...

positive control shows weak agglutination reaction

FDAJun 21, 2005Nationwide• Dade Behring Inc.

Dade Behring: MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; ...

There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

FDAFeb 7, 2005IN, PR• Dade Behring

Dade Behring Inc. Rte 896, Glasgow Business Community: Advanced D-Dimer. Fibrinogen and fibrin split products Ca...

decrease in product stability after reconstitution and reduced stability on board certain instrument systems

FDADec 3, 2004Nationwide• Dade Behring Inc. Rte 896, Glasgow Business Community

Dade Behring Inc. Rte 896, Glasgow Business Community: StreamLab Analytical Workcell. General Purpose Laboratory...

Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.

FDANov 12, 2004IL, IN, MD +3 more• Dade Behring Inc. Rte 896, Glasgow Business Community

Dade Behring Inc. Rte 896, Glasgow Business Community: DispoSystem for BCT System.Model number OVFR03. Multipurp...

APTT determinations when using affected rotors may lead to incorrectly shortened times

FDAAug 27, 2004Nationwide• Dade Behring Inc. Rte 896, Glasgow Business Community

Dade Behring Inc. Rte 896, Glasgow Business Community: BC Thrombin Reagent . Thrombin Time Test

The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin

FDAJul 21, 2004CT, FL, IL +5 more• Dade Behring Inc. Rte 896, Glasgow Business Community

Dade Behring Inc. Rte 896, Glasgow Business Community: Berichrom Heparin Reagent (OWLD11). The reagent is a co...

Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.

FDAJun 7, 2004AZ, CA, CO +20 more• Dade Behring Inc. Rte 896, Glasgow Business Community

Dade Behring Inc. Rte 896, Glasgow Business Community: Pathromtin SL. Partial Thromboplastin Time Tests. The pro...

cloudy appearance or precipitate

FDAMar 1, 2004IN, PA• Dade Behring Inc. Rte 896, Glasgow Business Community

Dade Behring Inc Rte 896, Glasgow Business Community: Dimension TSPA (Total Prostate Specific Antigen) Flex Rea...

test results may be inaccurate by 0.2 to 0.5 ng/mL

FDAApr 21, 2003Nationwide• Dade Behring Inc Rte 896, Glasgow Business Community

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