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.

651–667 of 667

  • ModerateFDA (Devices)·Z-0408-2013·2012-11-28

    Siemens Dimension Vista Theophylline Cartridge Recalled for Abnormal Reaction Errors

    Siemens Healthcare Diagnostics is recalling Dimension Vista Theophylline cartridges due to 'Abnormal Reaction' errors triggered by atypical particle reagent aggregation.

    Product
    Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0253-2013·2012-11-14

    Siemens Dimension Vista Homocysteine Reagent Cartridges Recalled for Leaking

    Siemens Healthcare Diagnostics is recalling 583 cartons of Dimension Vista Homocysteine Reagent Cartridges because they are leaking from their wrappers.

    Product
    Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocystein
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2013·2012-11-07

    Siemens ADVIA Centaur BR Assay Recalled for Quality Control Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR Assay kits because quality control results fell outside expected ranges.

    Product
    Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2013·2012-10-17

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays because they may show higher imprecision when used on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2409-2012·2012-09-26

    Siemens ADVIA Centaur Prolactin Assay Recalled for Analytical Sensitivity Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Prolactin Assay and Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.

    Product
    ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2410-2012·2012-09-26

    Siemens ADVIA Centaur FSH Calibrator B Recalled for Analytical Sensitivity Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur FSH Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.

    Product
    ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2012·2012-09-12

    Siemens syngo Lab Data Manager Recall for Quality Control Defect

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager and Process Manager software due to a defect that may prevent the system from flagging quality control violations appropriately.

    Product
    syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple inter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2012·2012-09-12

    Siemens ADVIA Centaur Multi-Diluent 1 Recalled for Decreased Dilution Recovery

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Multi-Diluent 1 because it may show decreased dilution recovery when stored on-board the system.

    Product
    Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2283-2012·2012-09-05

    Siemens Stratus CS Acute Care D-dimer Calibrator Recall

    Siemens is recalling specific lots of D-dimer Calibrators that may cause instrument calibration errors.

    Product
    Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2012·2012-08-29

    Siemens EasyLink Informatic System Recalled for Quality Control Defect

    Siemens Healthcare Diagnostics is recalling 637 EasyLink Informatic Systems because they may fail to flag quality control violations, potentially affecting patient result verification.

    Product
    EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2228-2012·2012-08-29

    Siemens Syphilis Assay Recalled Due to Interference with Hepatitis B Testing

    Siemens is recalling ADVIA Centaur Syphilis Assay kits because they may interfere with Hepatitis B surface antigen testing, potentially affecting diagnostic accuracy.

    Product
    Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2182-2012·2012-08-15

    Siemens Dimension Reagent Management System Power Cord Recall

    Siemens Healthcare Diagnostics is recalling 2,554 Dimension Reagent Management System power cords due to a fire hazard caused by partial cord insertion.

    Product
    Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridg
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2173-2012·2012-08-15

    Siemens syngo Lab Data Manager Recall for Incorrect Coagulation Results

    Siemens is recalling 15 syngo Lab Data Manager units because they may display and transmit incorrect coagulation results to laboratory information systems.

    Product
    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2172-2012·2012-08-15

    Siemens EasyLink Informatics System Recalled for Incorrect Diagnostic Results

    Siemens Healthcare Diagnostics is recalling 237 EasyLink Informatics Systems because they may display and transmit incorrect results to Laboratory Information Systems when used with specific coagulation analyzers.

    Product
    EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2175-2012·2012-08-15

    Siemens Recalls Dimension Vista Vancomycin Reagent Cartridges

    Siemens is recalling Dimension Vista Vancomycin Reagent Cartridges because calibration failures prevent the vancomycin assay from running.

    Product
    Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1869-2012·2012-07-04

    Siemens B12 Reagent Cartridges Recalled for False Test Results

    Siemens is recalling B12 Flex reagent cartridges because Intrinsic Factor Blocking Antibodies can cause false high Vitamin B12 results.

    Product
    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2012·2012-07-04

    Siemens BCS Behring Coagulation System Recalled for Potential Test Errors

    Siemens Healthcare Diagnostics is recalling 186 BCS Behring Coagulation Systems because a specific sequence of tests may result in shortened clotting times.

    Product
    BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
    Category
    Medical Device
    Distribution
    Distributed nationwide