Siemens Healthcare Diagnostics, Inc.
444 recalls on record · Latest: Nov 19, 2025
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Apr 21, 2021
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Devices Moderate Mar 24, 2021
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
FDA Devices Moderate Mar 17, 2021
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellit…
FDA Devices Moderate Jan 20, 2021
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: inten…
FDA Devices Moderate Jan 20, 2021
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intend…
FDA Devices Moderate Jan 20, 2021
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: inten…
FDA Devices Moderate Dec 30, 2020
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl tr…
FDA Devices Moderate Dec 30, 2020
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl trans…
FDA Devices Moderate Oct 28, 2020
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline ph…
FDA Devices Moderate Oct 21, 2020
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human s…
FDA Devices Moderate Oct 21, 2020
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum…
FDA Devices Moderate Sep 23, 2020
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous o…
FDA Devices Moderate Sep 9, 2020
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac trop…
FDA Devices Moderate Aug 12, 2020
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
FDA Devices Moderate Jul 8, 2020
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software…
FDA Devices Moderate Jul 8, 2020
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laborato…
FDA Devices Moderate Jul 1, 2020
ADVIA Chemistry Calibrator
FDA Devices Moderate Jul 1, 2020
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
FDA Devices Moderate Jul 1, 2020
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
FDA Devices Moderate Jul 1, 2020
Atellica CH Chemistry Calibrator
FDA Devices Moderate Jun 17, 2020
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative mea…
FDA Devices Moderate Jun 17, 2020
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determinatio…
FDA Devices Moderate Jun 17, 2020
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated …
FDA Devices Moderate Jun 17, 2020
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of…
FDA Devices Moderate May 6, 2020
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
FDA Devices Moderate Apr 1, 2020
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use i…
FDA Devices Moderate Apr 1, 2020
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: D…
FDA Devices Moderate Apr 1, 2020
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 ass…
FDA Devices Moderate Apr 1, 2020
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
FDA Devices Moderate Mar 25, 2020
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - P…
FDA Devices Moderate Mar 25, 2020
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Ana…
FDA Devices Moderate Mar 11, 2020
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for t…
FDA Devices Moderate Mar 11, 2020
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is…
FDA Devices Moderate Feb 26, 2020
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
FDA Devices Moderate Feb 26, 2020
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of…
FDA Devices Moderate Feb 26, 2020
Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistr…
FDA Devices Moderate Feb 26, 2020
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
FDA Devices Moderate Feb 26, 2020
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
FDA Devices Moderate Feb 5, 2020
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, cli…
FDA Devices Moderate Jan 29, 2020