The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics, Inc.

667 recalls in our database name Siemens Healthcare Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
667
Critical
5
Severe
12
Most recent
2026-08-26

Of the 667 recalls from Siemens Healthcare Diagnostics, Inc. we have scored against our rubric, 5 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

451–475 of 667

  • HighFDA (Devices)·Z-1030-2016·2016-03-09

    Siemens Dimension Vista B2 Microglobulin Reagent Cartridge Recall

    Siemens Healthcare Diagnostics is recalling Dimension Vista B2 Microglobulin reagent cartridges due to increased abnormal assay errors and calibration failures that may produce inaccurate patient results.

    Product
    Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinize
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0824-2016·2016-03-02

    Siemens BCS Blood Coagulation Analyzer Recall for False Results

    Siemens is recalling BCS Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low PT INR values when testing specific types of patient samples.

    Product
    BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 1046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2016·2016-03-02

    Siemens BCS XP Analyzer Recalled for False Clotting Results

    Siemens Healthcare Diagnostics is recalling BCS XP Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low INR values for specific patient samples.

    Product
    BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0754-2016·2016-02-10

    Siemens ADVIA Centaur PSA Assay Recalled for High Dose Hook Effect Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits because they do not meet the High Dose Hook Effect expectation in the Instructions for Use.

    Product
    ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0755-2016·2016-02-10

    Siemens ADVIA Chemistry XPT Systems Recalled for Multiple Software Issues

    Siemens Healthcare Diagnostics is recalling 87 ADVIA Chemistry XPT Systems due to software defects that may cause test failures, calibration errors, and system restarts.

    Product
    ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (IS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0616-2016·2016-01-13

    Siemens Acute Care CCRP CalPak Recall for Barcode Scanning Issues

    Siemens is recalling 65 units of Acute Care CCRP CalPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0618-2016·2016-01-13

    Siemens Acute Care MYO DilPak Recall Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 192 units of Acute Care MYO DilPak in vitro diagnostic products because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2016·2016-01-13

    Siemens Acute Care DDMR TestPak Barcode Scanning Recall

    Siemens Healthcare Diagnostics is recalling Acute Care DDMR TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2016·2016-01-13

    Siemens Acute Care MYO TestPak Barcode Labels May Not Scan

    Siemens Healthcare Diagnostics Inc is recalling 608 units of Acute Care MYO TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0610-2016·2016-01-13

    Siemens Acute Care pBNP TestPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 1,157 Acute Care pBNP TestPaks because their barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2016·2016-01-13

    Siemens Acute Care CKMB TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 1,051 units of Acute Care CKMB TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2016·2016-01-13

    Siemens Acute Care CKMB DilPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2016·2016-01-13

    Siemens Acute Care BHCG CalPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Acute Care BHCG CalPak because the cartridge barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0614-2016·2016-01-13

    Siemens Acute Care CCRP TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2016·2016-01-13

    Siemens Acute Care BHCG TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 590 units of Acute Care BHCG TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0609-2016·2016-01-13

    Siemens Acute Care CTNI TestPak Barcode Scanning Recall

    Siemens Healthcare Diagnostics Inc is recalling 5,558 units of the Acute Care CTNI TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Safety Hazard

    Siemens is recalling 151 Reagent Management System units because missing safety covers expose electrical termination blocks, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling four Reagent Management System units because a missing safety cover exposes an electrical termination block, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling 106 Reagent Management System units because a missing safety cover exposes an electrical hazard on the compressor.

    Product
    Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2016·2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling Reagent Management System (RMS) modules for the Dimension RxL Max clinical chemistry system because some units have missing safety covers on electrical termination blocks.

    Product
    Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0468-2016·2015-12-30

    Siemens Factor VIII Chromogenic Assay Recalled for Irregular Curves

    Siemens Healthcare Diagnostics is recalling Factor VIII Chromogenic Assay kits due to irregular curves on specific Sysmex systems, which may cause erroneously increased results.

    Product
    Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0340-2016·2015-12-02

    Siemens ADVIA Chemistry Hemoglobin A1c Reagent Kits Recalled for Bias

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Chemistry Hemoglobin A1c reagent kits due to a positive bias that may result in inaccurate test results.

    Product
    ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0339-2016·2015-12-02

    Siemens Dimension Vista Magnesium Reagent Cartridge Recall for Low Results

    Siemens Healthcare Diagnostics is recalling 3,601 Dimension Vista magnesium reagent cartridges due to erroneous low results that may affect patient and quality control testing.

    Product
    Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2016·2015-11-04

    Siemens ADVIA Chemistry XPT Systems Recalled for Unflagged Electrode Errors

    Siemens is recalling ADVIA Chemistry XPT systems because unplugged electrodes may cause unflagged errors in sodium, potassium, or chloride results.

    Product
    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2816-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 49 RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
    Category
    Medical Device
    Distribution
    Distributed nationwide