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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.
March 25, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use
Hazard: Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.
March 11, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage:
Hazard: A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
March 11, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage:
Hazard: A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
March 11, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Hazard: Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.
March 4, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usag
Hazard: Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
February 26, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the c
Hazard: Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer.
February 26, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnos
Hazard: Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
February 26, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Hazard: There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
February 26, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Hazard: There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
February 26, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Hazard: There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
February 26, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Hazard: There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
February 5, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930
Hazard: On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.
January 29, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Hazard: Homocysteine Assay May Cause Elevated Results in the Folate Assay
January 29, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Hazard: Homocysteine Assay May Cause Elevated Results in the Folate Assay
January 29, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Hazard: Homocysteine Assay May Cause Elevated Results in the Folate Assay
December 4, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer
Hazard: Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
October 30, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Hazard: Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
October 30, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Hazard: Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
October 23, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chem
Hazard: Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
October 2, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: Th
Hazard: Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure
August 28, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, u
Hazard: Iincreased (falsely elevated) Albumin results compared to expected results
August 28, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874
Hazard: There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
August 28, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Hazard: There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
August 14, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intend
Hazard: Negative Bias with Lot EA9227.
August 7, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of card
Hazard: Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
July 10, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA
Hazard: A steady upward trend in blank (u) absorbance was observed
July 10, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The A
Hazard: A steady upward trend in blank (u) absorbance was observed
May 15, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica Sample Handler Prime, Material Number 11069001
Hazard: There were multiple issues identified in the system software which required an update.
May 15, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1600 Analyzer, Material Number 11066000
Hazard: There were multiple issues identified in the system software which required an update.
May 15, 2019Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1300 Analyzer, Material Number 11066001
Hazard: There were multiple issues identified in the system software which required an update.