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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.
May 7, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics recalls IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Sie
Hazard: Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.
May 7, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics recalls IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siem
Hazard: Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
May 7, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics recalls IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products
Hazard: Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
March 5, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrat
Hazard: Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).
February 19, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 12
Hazard: The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
February 12, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quanti
Hazard: ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.
February 12, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantit
Hazard: ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.
February 5, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics recalls T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Numbe
Hazard: Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.
February 5, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics recalls T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use wit
Hazard: Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.
February 5, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5
Hazard: When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method.
January 29, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network so
Hazard: Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.)
January 29, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of c
Hazard: Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
January 29, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on hu
Hazard: An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
January 15, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dim
Hazard: Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
January 15, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dime
Hazard: Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
January 1, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics recalls IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380
Hazard: potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached.
January 1, 2014Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R
Hazard: Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l
December 25, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the qu
Hazard: Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
December 25, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quanti
Hazard: Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.
December 11, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments,
Hazard: Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.
December 11, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3
Hazard: There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1
November 27, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SM
Hazard: Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of
November 27, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein
Hazard: Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
November 27, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein
Hazard: Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
November 27, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for sp
Hazard: Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
November 27, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for sp
Hazard: Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
November 13, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Hazard: Imprecision with certain lots
November 13, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibratin
Hazard: PTH Calibrator packaged with only high calibrator.
November 6, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems a
Hazard: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
November 6, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems a
Hazard: RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample