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Siemens Healthcare Diagnostics, Inc.

467 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Prod recall (Z-2228-2012)Siemens Healthcare Diagnostics, Inc2012-08-20
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System i recall (Z-2172-2012)Siemens Healthcare Diagnostics, Inc.2012-08-09
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data c recall (Z-2173-2012)Siemens Healthcare Diagnostics, Inc.2012-08-09
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the q recall (Z-2175-2012)Siemens Healthcare Diagnostics, Inc.2012-08-09
Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnost recall (Z-2182-2012)Siemens Healthcare Diagnostics, Inc.2012-08-09
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent C recall (Z-1869-2012)Siemens Healthcare Diagnostics, Inc.2012-06-27
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose s recall (Z-1867-2012)Siemens Healthcare Diagnostics, Inc.2012-06-26
Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge Product Usage recall (Z-1540-2012)Siemens Healthcare Diagnostics, Inc.2012-05-11
Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute recall (Z-1516-2012)Siemens Healthcare Diagnostics, Inc.2012-05-10
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Nu recall (Z-1497-2012)Siemens Healthcare Diagnostics, Inc.2012-05-08
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, recall (Z-1498-2012)Siemens Healthcare Diagnostics, Inc.2012-05-08
MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, recall (Z-1499-2012)Siemens Healthcare Diagnostics, Inc.2012-05-08
Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista recall (Z-1454-2012)Siemens Healthcare Diagnostics, Inc.2012-04-25
Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in recall (Z-1433-2012)Siemens Healthcare Diagnostics, Inc.2012-04-17
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Pac recall (Z-1391-2012)Siemens Healthcare Diagnostics, Inc.2012-04-10
Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 0461004 recall (Z-1390-2012)Siemens Healthcare Diagnostics, Inc2012-04-09
Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use recall (Z-1268-2012)Siemens Healthcare Diagnostics, Inc2012-03-21
ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (12 recall (Z-1186-2012)Siemens Healthcare Diagnostics, Inc2012-03-07
Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit b recall (Z-1043-2012)Siemens Healthcare Diagnostics, Inc.2012-02-16
Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro diagnos recall (Z-0772-2012)Siemens Healthcare Diagnostics, Inc.2012-01-15
ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 1235 recall (Z-0489-2012)Siemens Healthcare Diagnostics, Inc2012-01-11
Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) l recall (Z-0513-2012)Siemens Healthcare Diagnostics, Inc.2012-01-11
Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A is f recall (Z-0644-2012)Siemens Healthcare Diagnostics, Inc.2012-01-11
Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Sta recall (Z-0645-2012)Siemens Healthcare Diagnostics, Inc.2012-01-11
Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the recall (Z-0646-2012)Siemens Healthcare Diagnostics, Inc.2012-01-11
Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent C recall (Z-0069-2012)Siemens Healthcare Diagnostics, Inc.2011-10-19
Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrato recall (Z-0038-2012)Siemens Healthcare Diagnostics, Inc.2011-10-12
Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension V recall (Z-0031-2012)Siemens Healthcare Diagnostics, Inc.2011-10-07
Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in recall (Z-3039-2011)Siemens Healthcare Diagnostics, Inc.2011-08-19
Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagn recall (Z-2177-2011)Siemens Healthcare Diagnostics, Inc.2011-05-10
Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) recall (Z-2154-2011)Siemens Healthcare Diagnostics, Inc.2011-05-09
Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in recall (Z-1739-2011)Siemens Healthcare Diagnostics, Inc.2011-03-21
Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute Care recall (Z-1732-2011)Siemens Healthcare Diagnostics, Inc.2011-03-18
ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code: recall (Z-1477-2011)Siemens Healthcare Diagnostics, Inc2011-03-02
Dimension LIP Flex Reagent Cartridge, Catalog# DF55A recall (Z-0588-2011)Siemens Healthcare Diagnostics, Inc.2010-12-10
The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthc recall (Z-0458-2011)Siemens Healthcare Diagnostics, Inc.2010-11-24
The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Si recall (Z-0459-2011)Siemens Healthcare Diagnostics, Inc.2010-11-24
The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healt recall (Z-0460-2011)Siemens Healthcare Diagnostics, Inc.2010-11-24
The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic Pept recall (Z-0461-2011)Siemens Healthcare Diagnostics, Inc.2010-11-24
Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus( recall (Z-0343-2011)Siemens Healthcare Diagnostics, Inc.2010-11-10
Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on th recall (Z-0139-2011)Siemens Healthcare Diagnostics, Inc.2010-10-25
EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classi recall (Z-0121-2011)Siemens Healthcare Diagnostics, Inc.2010-10-21
Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic te recall (Z-2419-2010)Siemens Healthcare Diagnostics, Inc.2010-09-16
Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with A recall (Z-2423-2010)Siemens Healthcare Diagnostics, Inc.2010-09-15
Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostic recall (Z-2407-2010)Siemens Healthcare Diagnostics, Inc.2010-09-13
Stratus CS Acute Care Troponin I TestPak ( Troponin I assay) recall (Z-2400-2010)Siemens Healthcare Diagnostics, Inc.2010-09-11
Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, recall (Z-2387-2010)Siemens Healthcare Diagnostics, Inc.2010-09-09
Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension syste recall (Z-2385-2010)Siemens Healthcare Diagnostics, Inc.2010-09-08
Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS85 recall (Z-2117-2010)Siemens Healthcare Diagnostics, Inc.2010-08-02
IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation recall (Z-1891-2010)Siemens Healthcare Diagnostics Inc.2010-06-24
Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of recall (Z-1535-2010)Siemens Healthcare Diagnostics, Inc.2010-05-04
Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers recall (Z-1205-2010)Siemens Healthcare Diagnostics, Inc.2010-03-24
IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 recall (Z-1033-2010)Siemens Healthcare Diagnostics Inc.2010-03-10
Dimension Vista V-LYTE Fluids: Standard A catalog number K820 recall (Z-1037-2010)Siemens Healthcare Diagnostics, Inc.2010-03-10
Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825 recall (Z-1038-2010)Siemens Healthcare Diagnostics, Inc.2010-03-10
Dimension Vista V-LYTE Fluids: Diluent catalog number K835 recall (Z-1039-2010)Siemens Healthcare Diagnostics, Inc.2010-03-10
IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 recall (Z-1066-2010)Siemens Healthcare Diagnostics Inc.2010-03-10
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnost recall (Z-1017-2010)Siemens Healthcare Diagnostics, Inc.2010-03-08
RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions pri recall (Z-1019-2010)Siemens Healthcare Diagnostics Inc2010-03-08
RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed recall (Z-1020-2010)Siemens Healthcare Diagnostics Inc2010-03-08
Dimension Vista LOCI Reaction Vessel recall (Z-0980-2010)Siemens Healthcare Diagnostics, Inc.2010-03-05
Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension V recall (Z-0864-2010)Siemens Healthcare Diagnostics, Inc.2010-02-26
Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521. Int recall (Z-0858-2010)Siemens Healthcare Diagnostics, Inc.2010-02-25
EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista recall (Z-1991-2009)Siemens Healthcare Diagnostics, Inc.2009-09-29
Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagno recall (Z-1930-2009)Siemens Healthcare Diagnostics, Inc.2009-09-08
Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimens recall (Z-1731-2009)Siemens Healthcare Diagnostics, Inc.2009-08-12
Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, recall (Z-1606-2008)Siemens Healthcare Diagnostics Inc.2008-06-28
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