Siemens Healthcare Diagnostics, Inc.: Medical Device Recalls in 2018
Updated on March 25, 2026.
According to to data from the FDA, there were 83 medical device recalls made by Siemens Healthcare Diagnostics, Inc. in 2018. See the details of the recalls below.
You can see similar recalls for other firms.
Data Source: FDA.
- Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
- Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
- Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 00630414949796; Dimension¿ RxL Max HM STM 00630414949819; Dimension¿ Xpand¿ Plus 00630414949833; Dimension¿ Xpand¿ Plus HM 00630414949840; Dimension¿ RxL Max Refurbished 00630414592947; Dimension¿ RxL Max HM Refurbished 00630414592954; Dimension¿ Xpand¿ Plus Refurbished 00630414592961; Dimension¿ Xpand¿ Plus HM Refurbished 00630414592978; Dimension¿ EXL with LM Refurbished 00630414000268; Dimension¿ 200 Refurbished 00630414010717;; Dimension¿ RxL Max w/o HM International 00630414949802; Dimension¿ RxL Max HM International 00630414945477; Dimension¿ RxL Max HM STM International 00630414949826; Dimension¿ Xpand Plus w/o HM International 00630414949857; Dimension¿ Xpand Plus w/HM International 00630414945484; Dimension¿ EXL with LM International 00842768030024; Dimension¿ EXL 200 International 00842768037214 Dimension¿ EXL with LM with STM International 00630414593609 The Dimension motor assembly is used in the Dimension Thermal Chamber Fan (ASSY BLOWER SNOUT) and is responsible for the intake and circulation of air inside the "Wok," a chamber within the Dimension instrument which enables greater temperature control of the testing environment.
- Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
- Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
- Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
- Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
- Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.
- Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
- RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
- Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
- RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample.
- Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
- RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
- Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
- RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
- IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
- ADVIA Centaur¿ Cyclosporine
- Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
- ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
- Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
- ADVIA Centaur¿ DHEA-SO4
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
- ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
- Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- ADVIA Centaur¿ HBc IgM
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
- Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
- Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
- Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
- ADVIA Centaur¿ Folate (FOL)
- IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
- ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
- Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
- IMMULITE ¿ /IMMULITE ¿ 1000 CEA
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
- Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
- ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories)
- Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
- Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
- Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
- Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
- ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
- IMMULITE ¿ /IMMULITE ¿ 1000 TG
- Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
- Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
- Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
- IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
- Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
- Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
- STREAMLAB CORE UNIT / LYNX WITH IOM
- Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
- APTIO RACK OUTPUT MODULE
- Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
- Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- APTIO INPUT/OUTPUT MODULE
- STREAMLAB - REFRIGERATED STORAGE MODULE 9000
- APTIO 15000 REFRIGERATED STORAGE MODULE
- STREAMLAB - REFRIGERATED STORAGE MODULE 15000
- Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- APTIO RACK INPUT MODULE
- Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323
- APTIO 9000 REFRIGERATED STORAGE MODULE
- APTIO CENTRIFUGE MODULE
- Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
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