PlainRecalls

Siemens Healthcare Diagnostics, Inc.

Compiled from official public sources by the publisher.

665 recalls on record · Latest: Aug 12, 2026

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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 · 2026-09-13

Siemens Healthcare Diagnost… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Siemens Healthcare Diagnostics, Inc. carries 665 distinct federal notices, ranked #6 of 14,151 (heavy-book).

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Low Aug 12, 2026

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
FDA Devices Moderate Aug 12, 2026

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
FDA Devices Low Aug 12, 2026

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
FDA Devices Moderate Jul 15, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
FDA Devices Moderate Jun 17, 2026

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
FDA Devices Moderate May 6, 2026

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
FDA Devices Moderate May 6, 2026

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
FDA Devices Moderate Apr 8, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
FDA Devices Moderate Mar 11, 2026

Atellica CH Urine Albumin (UAlb). Material Number: 11537225
FDA Devices Moderate Nov 19, 2025

Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
FDA Devices Moderate Nov 19, 2025

3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;
FDA Devices Moderate Nov 19, 2025

IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
FDA Devices Moderate Nov 5, 2025

Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
FDA Devices Moderate Sep 17, 2025

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
FDA Devices Moderate Aug 13, 2025

epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
FDA Devices Moderate Aug 6, 2025

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i SETpoint Calibrator
FDA Devices Moderate Jul 2, 2025

Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
FDA Devices Moderate Jun 4, 2025

Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
FDA Devices Moderate Jun 4, 2025

ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
FDA Devices Moderate May 7, 2025

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
FDA Devices Moderate May 7, 2025

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
FDA Devices Moderate May 7, 2025

epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
FDA Devices Moderate Apr 16, 2025

Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
FDA Devices Moderate Jan 1, 2025

Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Devices Moderate Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Devices Moderate Dec 11, 2024

Atellica CI Analyzer. Catalog Numbers: 10947347.
FDA Devices Moderate Dec 11, 2024

Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
FDA Devices Moderate Nov 27, 2024

Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
FDA Devices Moderate Nov 20, 2024

IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
FDA Devices Moderate Nov 13, 2024

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
FDA Devices Moderate Oct 9, 2024

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
FDA Devices Moderate Oct 9, 2024

ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
FDA Devices Moderate Sep 25, 2024

Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
FDA Devices Moderate Sep 25, 2024

ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.
FDA Devices Moderate Sep 18, 2024

Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490
FDA Devices Moderate Sep 18, 2024

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
FDA Devices Moderate Sep 18, 2024

Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
FDA Devices Moderate Sep 18, 2024

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
FDA Devices Moderate Sep 18, 2024

ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239

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).

Icu Medical, Inc. 657 Newly Weds Foods, Inc. 657 Customed, Inc 682 Garden Fresh Foods, Inc. 634 Boston Scientific Corporation 632

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Icu Medical, Inc. 657 Customed, Inc 682 Boston Scientific Corporation 632 Siemens Medical Solutions USA, Inc 796

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