Siemens Healthcare Diagnostics, Inc.
665 recalls on record · Latest: Aug 12, 2026
Subscribe to new Siemens Healthcare Diagnost… recalls (RSS)
Agency notice ledger
Federal filing book Siemens Healthcare Diagnost… HEAVY-BOOK · SINGLE-AGENCY
#6 of 14,151 · 665 notices · 0.637% archive
- BOOK 665 notices
- RANK #6 of 14,151
- SHARE 0.637% archive
- AGENCY FDA Devices (665)
- CAT medical devices
- CATS 1 category
- LATEST Aug 12, 2026
- PHOTO Icu Medical, Inc.
Nearest notice-volume peer: Icu Medical, Inc. (8 notice gap)
Siemens Healthcare Diagnostics, Inc. sits #6 of 14,151 (6th among 14,151 firms) with 665 federal notices — about 0.637% of the archive (heavy-book tercile). Rank counts issuance frequency, not danger. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
How Siemens Healthcare Diagnost… compares to 14,151 recalling firms
Siemens Healthcare Diagnostics, Inc. ranks 6th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Siemens Healthcare Diagnost… vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
665 6th of 14151 higher than 14,145 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14
Siemens Healthcare Diagnost… in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Customed, Inc
Customed, Inc
682 notices
- Siemens Healt… (this)
Siemens Healthcare Diagnostics, Inc.
665 notices
- Icu Medical,…
Icu Medical, Inc.
657 notices
- Newly Weds Fo…
Newly Weds Foods, Inc.
657 notices
- Garden Fresh…
Garden Fresh Foods, Inc.
634 notices
- Boston Scient…
Boston Scientific Corporation
632 notices
What this shows Siemens Healthcare Diagnostics, Inc. carries 665 distinct federal notices, ranked #6 of 14,151 (heavy-book).
FDA Devices Moderate Jun 17, 2020
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
FDA Devices Moderate May 6, 2020
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
FDA Devices Moderate Apr 1, 2020
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry systems. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disord
FDA Devices Moderate Apr 1, 2020
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder diseas
FDA Devices Moderate Apr 1, 2020
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of
FDA Devices Moderate Apr 1, 2020
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
FDA Devices Moderate Apr 1, 2020
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.
FDA Devices Moderate Apr 1, 2020
Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista¿ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease
FDA Devices Moderate Apr 1, 2020
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
FDA Devices Moderate Mar 25, 2020
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.
FDA Devices Moderate Mar 25, 2020
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.
FDA Devices Moderate Mar 11, 2020
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.
FDA Devices Moderate Mar 11, 2020
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.
FDA Devices Moderate Mar 11, 2020
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
FDA Devices Moderate Mar 4, 2020
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
FDA Devices Moderate Feb 26, 2020
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
FDA Devices Moderate Feb 26, 2020
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
FDA Devices Moderate Feb 26, 2020
Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay
FDA Devices Moderate Feb 26, 2020
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
FDA Devices Moderate Feb 26, 2020
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
FDA Devices Moderate Feb 26, 2020
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
FDA Devices Moderate Feb 5, 2020
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.
FDA Devices Moderate Jan 29, 2020
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
FDA Devices Moderate Jan 29, 2020
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
FDA Devices Moderate Jan 29, 2020
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
FDA Devices Moderate Dec 4, 2019
Atellica CH 930 Analyzer
FDA Devices Moderate Oct 30, 2019
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
FDA Devices Moderate Oct 30, 2019
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
FDA Devices Moderate Oct 23, 2019
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
FDA Devices Moderate Oct 2, 2019
Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA)
FDA Devices Moderate Aug 28, 2019
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
FDA Devices Moderate Aug 28, 2019
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
FDA Devices Moderate Aug 28, 2019
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
FDA Devices Moderate Aug 14, 2019
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.
FDA Devices Moderate Aug 7, 2019
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
FDA Devices Moderate Jul 10, 2019
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
FDA Devices Moderate Jul 10, 2019
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
FDA Devices Moderate May 15, 2019
Atellica IM 1600 Analyzer, Material Number 11066000
FDA Devices Moderate May 15, 2019
Atellica Sample Handler Prime, Material Number 11069001
FDA Devices Moderate May 15, 2019
Atellica IM 1300 Analyzer, Material Number 11066001
FDA Devices Moderate May 8, 2019
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
FDA Devices Moderate May 8, 2019
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
FDA Devices Moderate May 8, 2019
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
FDA Devices Moderate May 8, 2019
Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
FDA Devices Moderate Apr 24, 2019
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
FDA Devices Moderate Mar 27, 2019
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
FDA Devices Moderate Mar 27, 2019
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
FDA Devices Moderate Feb 6, 2019
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Devices Moderate Feb 6, 2019
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Devices Moderate Feb 6, 2019
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000
Siemens Healthcare Diagnost… sits in the heavy federal notice book
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (665 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Siemens Healthcare Diagnost…? ▼
PlainRecalls indexes 665 distinct federal recall events naming Siemens Healthcare Diagnostics, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Siemens Healthcare Diagnost… sit among other recalling firms? ▼
Siemens Healthcare Diagnostics, Inc. ranks #6 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Siemens Healthcare Diagnost…'s notices? ▼
FDA Devices accounts for 665 of this firm's 665 indexed notices.
What product category dominates Siemens Healthcare Diagnost…'s filing book? ▼
Filings for Siemens Healthcare Diagnostics, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Siemens Healthcare Diagnostics, Inc.: 665 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Siemens Healthcare Diagnostics, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026