Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2025, with 27 FDA device recalls on record.
Top product codes for Siemens Healthcare Diagnostics
FDA recalls by Siemens Healthcare Diagnostics
10 most recent of 27- Z-0827-2018 — BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.
- Z-0122-2015 — IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
- Z-2715-2014 — ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
- Z-2716-2014 — ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
- Z-2662-2014 — ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
- Z-2663-2014 — ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
- Z-2643-2014 — ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
- Z-1553-2014 — ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
- Z-1532-2014 — IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum.
- Z-1517-2014 — IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Siemens Healthcare Diagnostics
- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more
- K162977 — ADVIA 2120i, ADVIA 2120
- K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL
- K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
- K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
- K151964 — Xprecia Stride Coagulation System, Xprecia System PT Controls
- K150168 — Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
- K143720 — Dimension Vista MMB Assay
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K150132 — IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
- K143639 — IMMULITE 2000 CEA Calibration Verification Material
- K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
- K133512 — LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
- K122539 — MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
- K130698 — DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
- K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
- K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
- K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
- K123321 — DIMENSION CHEMISTRY III CALIBRATORY
- K122323 — DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
- K121907 — DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
- K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER
- K102644 — ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
- K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM
- K112142 — DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
- K110061 — CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
- K110934 — ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
- K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN
- K101572 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K110303 — STRATUS CS ACUTE CARE D-DIMER
- K102510 — DIMENSIONS HB1C KIT, MODEL DF105A
- K103683 — IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
- K100344 — DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
- K100321 — DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
- K110169 — DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
- K101854 — ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
- K093626 — INNOVANCE D-DIMER, MODEL OPBP09
- K102904 — ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
- K093107 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K101425 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
- K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
- K090346 — ADVIA 2120/2120I BODY FLUIDS
- K101460 — LOCI 8 CALIBRATOR, MODEL KC 646
- K093939 — ADVIA CHEMISTRY SALICYLATE REAGENT
- K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
- K100289 — ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
- K100778 — DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
- K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
- K093732 — ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
- K093645 — EXL ANEM CAL, MODEL RC640
- K093631 — B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
- K091949 — MICROSCAN MICROSTREP PLUS, MODEL B1027-201
- K091867 — ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
- K091361 — IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
- K092993 — ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
- K091916 — INNOVANCE D-DIMER, MODEL OPBP09
- K092919 — MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
- K092283 — DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
- K091216 — CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
- K091123 — ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
- K091289 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K091264 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
- K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
- K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
- K090257 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K083844 — ADVIA CENTAUR TSH3-ULTRA METHOD
- K090594 — DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
- K090236 — DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
- K083386 — ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
- K083487 — EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
- K083445 — N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
- K083853 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K083463 — DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
- K083314 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K083906 — ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
- K083462 — DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
- K083465 — DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
- K083579 — DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
- K083262 — MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
- K083159 — BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
- K083175 — BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
- K082503 — DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
- K071474 — DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
- K081732 — INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
- K082680 — LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
- K082645 — DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
- K081013 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
- K081731 — DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
- K080167 — ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
- K081683 — LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
- K081643 — DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
- K081300 — DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.