The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics

27 recalls in our database name Siemens Healthcare Diagnostics as the manufacturing or recalling firm.

What the numbers show

Total
27
Critical
0
Severe
0
Most recent
2018-03-07

Of the 27 recalls from Siemens Healthcare Diagnostics we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–25 of 27

  • ModerateFDA (Devices)·Z-0827-2018·2018-03-07

    Siemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results

    Siemens Healthcare Diagnostics is recalling specific lots of BC Thrombin Reagent Kits because they may produce unexpectedly prolonged Thrombin Time results for normal samples.

    Product
    BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0122-2015·2014-10-29

    Siemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 1000 Cortisol Assay reagents due to confirmed positive bias on controls.

    Product
    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2716-2014·2014-10-08

    Siemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay Systems because patient demographic data may incorrectly merge with subsequent orders under rare circumstances.

    Product
    ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical di
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2715-2014·2014-10-08

    Siemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Immunoassay Systems because patient demographic data may be incorrectly merged under rare circumstances.

    Product
    ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagn
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2643-2014·2014-09-24

    Siemens ADVIA Chemistry A1c_3 Calibrator Recalled for Potential Bias

    Siemens is recalling ADVIA Chemistry A1c_3 Calibrators because they may cause a percent bias in HbA1c test results.

    Product
    ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total He
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2662-2014·2014-09-24

    Siemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading

    Siemens is correcting ADVIA Centaur systems where improperly loaded sample racks may cause sample ID misreads.

    Product
    ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2663-2014·2014-09-24

    Siemens ADVIA Centaur Immunoassay Systems Recalled for Sample Rack Loading Issues

    Siemens Healthcare Diagnostics is correcting ADVIA Centaur and XP systems where improperly loaded sample racks may cause sample ID misreads.

    Product
    ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnosti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2014·2014-05-14

    Siemens ADVIA Centaur XP Immunoassay System Recalled for Gas Spring Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay systems because gas springs may fail, causing the instrument cover to fall.

    Product
    ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2014·2014-05-07

    Siemens Androstenedione Assay Recall Due to Over-Recovery

    Siemens recalls Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL limit.

    Product
    IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Ana
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1531-2014·2014-05-07

    Siemens IMMULITE Androstenedione Assay Recalled for Over-Recovery

    Siemens recalls IMMULITE Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL linearity limit.

    Product
    IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1517-2014·2014-05-07

    Siemens IMMULITE Total IgE Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling IMMULITE Total IgE assays due to a confirmed 23% positive bias against the WHO 2nd IRP 75/502.

    Product
    IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1518-2014·2014-05-07

    Siemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 2000 Total IgE assays because they show a 23% positive bias against the WHO standard.

    Product
    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0867-2014·2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products Lt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2014·2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare Diagnost
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0569-2014·2014-01-01

    Siemens IMMULITE Folic Acid Kits Recalled for Potential Expiration Issues

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE Folic Acid kits due to a potential accelerated decline in counts that may cause failed adjustments before expiration.

    Product
    IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1650 system software due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Parameter Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1800 System Software V2.01 due to ration parameters flagging behavior issues.

    Product
    ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2014·2013-11-27

    Siemens ADVIA 1200 Software Recalled for Ration Parameter Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1200 System Software versions 2.00 and 2.01 due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0346-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 2400 System Software V4.01 due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0365-2014·2013-11-27

    Siemens Chemistry Calibrator Recall for Direct Bilirubin Assay Shift

    Siemens is recalling Chemistry Calibrators for the Direct Bilirubin Assay because reassigned System Specific Values may cause an average shift in results.

    Product
    Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of dir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2014·2013-10-23

    Siemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk

    Siemens is recalling ADVIA 2120/2120i hematology systems connected to an ADVIA Autoslide because a rack jam error could cause the next slide to be labeled with the wrong sample identification information.

    Product
    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2013·2013-09-11

    Siemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.

    Product
    ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2013·2013-09-04

    Siemens ADVIA 120 Hematology Analyzer Recall for Optics Cover Failure

    Siemens is recalling ADVIA 120 Hematology Analyzers because gas struts may fail, causing the top optics cover to fall during maintenance.

    Product
    ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2047-2013·2013-09-04

    Siemens PSA Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling PSA Assay kits for use in IMMULITE systems due to a confirmed positive bias of 20% to 23% in patient results.

    Product
    PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2013·2013-01-16

    Siemens Healthcare Recalls TSH Calibrator Vials Due to Dose Recovery Issues

    Siemens Healthcare Diagnostics is recalling specific lots of TSH calibrator vials because they showed under-recovery of dose values.

    Product
    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
    Category
    Medical Device
    Distribution
    8 states