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Siemens Healthcare Diagnostics Recalls
692 recalls on record · July 4, 2012 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 23, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
Hazard: Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
November 23, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
Hazard: Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
November 2, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (U
Hazard: Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
November 2, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number
Hazard: Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
October 19, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number
Hazard: Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
October 19, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN)
Hazard: Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
October 19, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur XPT Immunoassay System
Hazard: The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.
October 12, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
Hazard: Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
October 12, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
Hazard: Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
October 12, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Hazard: Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
October 5, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centa
Hazard: Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
September 28, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum o
Hazard: 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.
September 21, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
Hazard: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
September 21, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
Hazard: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
September 21, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
Hazard: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
September 21, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
Hazard: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
September 21, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
Hazard: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
September 21, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193
Hazard: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
September 21, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,1032265
Hazard: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
September 14, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Hazard: Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
September 7, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretr
Hazard: Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ratio equation used to calculate ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results in IFCC units contains an error. The error results in falsely depressed HbA1cR results.
August 31, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is
Hazard: Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
August 17, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body flui
Hazard: Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
August 3, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analy
Hazard: Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples
August 3, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in
Hazard: Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples.
July 27, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806),
Hazard: Eight (8) issues were identified which may affect the results generated by the system software version.
July 6, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc. recalls Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10
Hazard: Premature bucket failures
June 29, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponi
Hazard: Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin
June 8, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc. recalls Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D0113
Hazard: Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.
June 8, 2016Medical DevicesFDA
Siemens Healthcare Diagnostics Inc. recalls Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D01137
Hazard: Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.