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Siemens Healthcare Diagnostics Recalls
692 recalls on record · July 4, 2012 to August 12, 2026 · Medical Devices
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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 6, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems
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¿ 1240 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 RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is
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 RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and l
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 RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and lab
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
October 23, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / C
Hazard: Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
October 23, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATI
Hazard: Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative det
Hazard: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative dete
Hazard: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determina
Hazard: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determi
Hazard: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & Micro
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & Micro
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroS
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Pan
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels &
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & M
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Ra
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroSca
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 18, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Ra
Hazard: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
September 11, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators
Hazard: Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use ¿ 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected..
September 4, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that
Hazard: The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.
September 4, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6.
Hazard: Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot
September 4, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in t
Hazard: Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO). Other commercially available controls may show this bias.
August 21, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). F
Hazard: Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
August 14, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an
Hazard: Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.
August 14, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is
Hazard: Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
August 14, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitativel
Hazard: A rare variant of TSH, identified in a small cluster of patients, is not detected.