Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2026, with 667 FDA device recalls on record.
Top product codes for Siemens Healthcare Diagnostics, Inc.
FDA recalls by Siemens Healthcare Diagnostics, Inc.
10 most recent of 667- Z-2976-2026 — Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
- Z-2975-2026 — Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- Z-2890-2026 — Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
- Z-2881-2026 — Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
- Z-2880-2026 — Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
- Z-2703-2026 — Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- Z-2398-2026 — Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
- Z-2005-2026 — epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
- Z-1980-2026 — Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
- Z-1657-2026 — Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
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, Inc.
1–100 of 154- K253528 — Atellica IM CA 19-9 II
- K261364 — Atellica CH Acetaminophen 2 (ACTM)
- K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)
- K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII)
- K251630 — Atellica IM Total PSA II (tPSAII)
- K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII)
- K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II
- K242981 — Atellica IM Thyroglobulin (Tg)
- K242685 — Atellica® CH Creatinine_3 (Crea3)
- K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
- K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH)
- K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
- K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
- K220265 — ADVIA Centaur® NT-proBNPII (PBNPII)
- K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
- K221605 — Emit® II Plus Buprenorphine Assay
- K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl)
- K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
- K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil)
- K221801 — ADVIA Centaur® Anti-Müllerian Hormone (AMH)
- K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil)
- K221119 — RCRP Flex reagent cartridge
- K220262 — Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
- K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3)
- DEN190056 — ADVIA Centaur Enhanced Liver Fibrosis (ELF)
- K193397 — ADVIA Centaur® Digoxin assay
- K200210 — ADVIA Centaur® Total hCG assay
- K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
- K200509 — ADVIA Centaur Vitamin D Total (VitD)
- K200199 — ADVIA Centaur CA 125II
- K192240 — RAPIDPoint 500e Blood Gas System
- K193489 — ADVIA Centaur BR
- K193493 — ADVIA Centaur Total IgE (tIgE)
- K192788 — ADVIA Centaur Cortisol (COR)
- K192777 — ADVIA Centaur CA 15-3 assay
- K192790 — Atellica IM Total hCG (ThCG)
- K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
- K191454 — Atellica CH Amylase_2 (AMY_2)
- K191578 — ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
- K190675 — Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
- K182225 — Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
- K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
- K171566 — Atellica IM High-Sensitivity Troponin I (TNIH)
- K181002 — Atellica IM BRAHMS Procalcitonin (PCT)
- K173909 — Dimension Hemoglobin A1c Assay
- K171274 — ADVIA Centaur High-Sensitivity Troponin I (TNIH)
- K181082 — ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
- K172201 — Atellica IM Folate Assay
- K172322 — Atellica IM Total hCG (ThCG)
- K171771 — ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
- K170293 — Emit II Plus Cocaine Metabolite Assay
- K172910 — Emit II Plus Oxycodone Assay
- K171642 — Atellica IM Ferritin Assay
- K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
- K163220 — Atellica CH Phencyclidine (Pcp)
- K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
- K162399 — Atellica CH Magnesium (Mg)
- K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
- K161964 — ADVIA Centaur HAV IgM Assay
- K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
- K151986 — ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
- K160647 — IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
- K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
- K152061 — IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
- K151529 — Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
- K142826 — ADVIA Centaur Toxoplasma M (Toxo M)
- K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
- K151767 — Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
- K151792 — Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
- K150606 — Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
- K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material
- K150039 — MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
- K150403 — ADVIA Centaur TSH3-Ultra
- K141999 — ADVIA CENTAUR TSH
- K142723 — ADVIA Centaur Cortisol (COR) Assy
- K143373 — IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
- K143636 — IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
- K143680 — ADVIA Centaur IgE Master Curve Material
- K143504 — IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
- K143352 — IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
- K143376 — ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material
- K142758 — ADVIA Centaur HAV total assay
- K143194 — ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)
- K140842 — DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
- K140859 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
- K142878 — IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
- K142811 — IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
- K142864 — ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
- K141772 — IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
- K133156 — ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY +1 more
- K141444 — IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
- K133816 — IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
- K132801 — IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
- K140818 — IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
- K140541 — IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
- K140505 — ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
- K140267 — ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
- K140258 — IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
- K133491 — ADVIA CENTAUR TESTOSTERONE (TSTO)
- K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.