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.

526–550 of 667

  • HighFDA (Devices)·Z-0148-2015·2014-11-05

    Siemens Phenytoin Reagent Cartridge Recalled for Potential Test Bias

    Siemens Healthcare Diagnostics is recalling 1,733 Phenytoin Flex Reagent Cartridges due to internal testing that confirmed a low absorbance range, which may result in biased or imprecise test results.

    Product
    siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2015·2014-11-05

    Siemens ADVIA Centaur Calibrator C Recalled for Ferritin Assay Sensitivity Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue affecting ferritin assay sensitivity.

    Product
    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0128-2015·2014-11-05

    Siemens Recalls ADVIA Centaur Ferritin Calibrator C Due to Analytical Sensitivity Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Ferritin Calibrator C kits due to realignment issues with specific kit lots. The recall affects 8,263 kits distributed worldwide.

    Product
    ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Kit Recalled for Increased Imprecision

    Siemens is recalling ADVIA Centaur HBc Total kits due to increased imprecision and positive bias that may cause false reactive results.

    Product
    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc Total reagents due to increased imprecision and positive bias that may cause false reactive results.

    Product
    Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the cor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0081-2015·2014-10-22

    Siemens Clinitek Status+ Power Supply Adapters Recalled for Electric Shock Risk

    Siemens Healthcare Diagnostics is recalling approximately 4,200 external power supply adapters for the Clinitek Status+ urine analyzer due to damage that can cause electric shock.

    Product
    External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2015·2014-10-22

    Siemens Clinitek Status Power Supply Adaptors Recalled for Electric Shock Risk

    Siemens Healthcare Diagnostics is recalling external power supply adaptors for the Clinitek Status urine analyzer because they are damaged and can cause electric shock.

    Product
    External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2015·2014-10-22

    Siemens Clinitek Status Power Supply Adaptors Recalled for Shock Risk

    Siemens Healthcare Diagnostics is recalling external power supply adaptors for the Clinitek Status urine analyzer due to damage that can cause electric shock.

    Product
    External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2015·2014-10-15

    Siemens Recalls Dimension Vista Mass CKMB Isoenzyme Calibrator Due to Drift

    Siemens Healthcare Diagnostics is recalling Dimension Vista Mass CKMB Isoenzyme Calibrators because routine stability monitoring showed drift exceeding acceptance criteria.

    Product
    Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2720-2014·2014-10-08

    Siemens Dimension Vista CHEM 1 CAL Recall for Magnesium Calibration Error

    Siemens is recalling Dimension Vista CHEM 1 CAL lot 3GM081 because it causes under-recovery of Magnesium in patient and QC samples.

    Product
    Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2665-2014·2014-09-24

    Siemens CentraLink Data Management System Software Recall for Timer Overflow

    Siemens is recalling CentraLink Data Management System software version 14 due to a task scheduler issue that may stop command execution and result uploads.

    Product
    Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2014·2014-09-10

    Siemens EasyLink Informatics System Recall for Potential Result Transmission Errors

    Siemens Healthcare Diagnostics is recalling the EasyLink Informatics System V4.0/V5 because it may release results to the Laboratory Information System that should have been held for manual review.

    Product
    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2014·2014-09-03

    Siemens Dimension EXL Chemistry System Recalled for Hinge Injury Risk

    Siemens is recalling 2,757 Dimension EXL Integrated Chemistry Systems because a reagent lid hinge may shift during maintenance, posing a risk of physical injury to operators.

    Product
    Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2014·2014-08-27

    Siemens Dimension Chemistry Wash Recalled for Inaccurate Test Results

    Siemens Healthcare Diagnostics is recalling Dimension Chemistry Wash lot RD41041 because it caused accuracy shifts in specific patient and QC test results.

    Product
    Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2149-2014·2014-08-13

    Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration

    Siemens is recalling 1,191 BNP immunoassay kits worldwide due to complaints of failed calibration. The kits are used for in vitro diagnostic testing.

    Product
    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2014·2014-08-13

    Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration

    Siemens Healthcare Diagnostics is recalling 961 BNP kits due to complaints of failed calibration. The kits are used for in vitro diagnostic testing of B-type Natriuretic Peptide.

    Product
    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2133-2014·2014-08-06

    Siemens Dimension Integrated Chemistry Systems Recalled for Photometer Misassembly

    Siemens is recalling 15 Dimension Integrated Chemistry Systems due to a photometer misassembly issue that may shorten the life of the source lamp.

    Product
    Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2079-2014·2014-07-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Electrolyte Error Codes

    Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Lactate Cartridges because they may display error codes for electrolyte parameters.

    Product
    RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2058-2014·2014-07-23

    Siemens Coat-A-Count Direct Androstenedione Assay Recalled for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling Coat-A-Count Direct Androstenedione assays because they show higher frequency of results greater than 10 ng/mL compared to other platforms.

    Product
    Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2014·2014-07-23

    Siemens RAPIDComm Data Management System Recalled for Incorrect Test Names

    Siemens Healthcare Diagnostics Inc is recalling six RAPIDComm Data Management Systems because the 5.0 screen layout displays incorrect test names.

    Product
    Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1991-2014·2014-07-09

    Siemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur TnI-Ultra assay kits because a darker solid phase reagent in some lots may lead to incorrect test results.

    Product
    ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1944-2014·2014-07-09

    Siemens syngo Lab Data Manager Software Recall for Configuration Errors

    Siemens is recalling syngo Lab Data Manager software because configuration errors may cause test results to bypass manual review and release to the Laboratory Information System.

    Product
    syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2014·2014-07-09

    Siemens MicroScan WalkAway Plus Instruments Recalled for Hinge Spring Failure

    Siemens is recalling MicroScan WalkAway-40 and 96 plus instruments because springs in the access door hinge assembly are detaching, causing premature failure and potential safety issues.

    Product
    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1960-2014·2014-07-09

    Siemens ADVIA Centaur HCY Diluent Recalled for Inaccurate Dilution Recovery

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HCY Diluent because dilution recovery was lower than reported in the instructions for use.

    Product
    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2014·2014-07-02

    Siemens StreamLAB Analytical Workcell Recalled for Trip and Fall Hazard

    Siemens is recalling 317 StreamLAB Analytical Workcells because protruding pins on the Input/Output Module have contributed to trip and fall incidents.

    Product
    Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide