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Dade Behring, Inc.

28 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. recall (Z-0668-2009)Dade Behring, Inc.2009-01-28
Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. Th recall (Z-0581-2009)Dade Behring, Inc.2009-01-13
Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vit recall (Z-0485-2009)Dade Behring, Inc.2008-12-13
EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING IN recall (Z-1174-2007)Dade Behring, Inc.2007-08-22
Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D; recall (Z-0247-2007)Dade Behring, Inc.2006-12-05
Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic. recall (Z-0874-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic. recall (Z-0875-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic. recall (Z-0876-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic. recall (Z-0877-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic. recall (Z-0878-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer Acute Care pBNP TestPak (CpBNP) in vitro diagnostic. recall (Z-0879-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic. recall (Z-0880-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic. recall (Z-0881-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic. recall (Z-0882-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic. recall (Z-0883-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic. recall (Z-0884-06)Dade Behring , Inc.2006-05-19
Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CpBNP-D) in vitro diagnostic recall (Z-0885-06)Dade Behring , Inc.2006-05-19
Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Cata recall (Z-0304-06)Dade Behring , Inc.2005-12-23
Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIM recall (Z-0172-06)Dade Behring , Inc.2005-11-18
Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test recall (Z-1374-05)Dade Behring , Inc.2005-08-16
Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E recall (Z-1040-05)Dade Behring , Inc.2005-07-22
Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13. recall (Z-0538-05)Dade Behring , Inc.2005-02-15
StreamLab Analytical Workcell. General Purpose Laboratory Device. recall (Z-0373-05)Dade Behring , Inc.2004-12-28
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulati recall (Z-0042-05)Dade Behring , Inc.2004-10-23
BC Thrombin Reagent . Thrombin Time Test recall (Z-0007-05)Dade Behring , Inc.2004-10-05
Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit. recall (Z-1305-04)Dade Behring , Inc.2004-07-31
Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 1 recall (Z-0773-04)Dade Behring , Inc.2004-07-20
Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is sh recall (Z-0873-03)Dade Behring Inc2003-05-29

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Every clearance here is in the API, with alerts when new ones post.