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Siemens Healthcare Diagnostics, Inc. Recalls

423 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Siemens Healthcare Diagnostics, Inc..

423Total Recalls
14Critical
15.1MUnits Affected
Mar 18, 2026Most Recent
All Recalls

Every Siemens Healthcare Diagnostics, Inc. Recall

Sorted by most recent. Click any recall for full details.

423 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·674 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·8 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·15 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·132 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·33 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·0 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·195 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·185 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·1 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·27 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·43 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·1,452 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behr...
Diagnostic Devices·1,547 affected·Mar 2, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Diagnostic Devices·390 affected·Feb 8, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as dia...
Diabetes Devices·4,174 affected·Feb 3, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product ...
Diagnostic Devices·1,095 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product U...
Diagnostic Devices·2,405 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product ...
Diagnostic Devices·1,588 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma...
Diagnostic Devices·731 affected·Nov 23, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-gl...
Diagnostic Devices·397 affected·Nov 23, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine...
Diagnostic Devices·23 affected·Sep 22, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in...
Diagnostic Devices·28 affected·Sep 22, 2020
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arteri...
Diagnostic Devices·463 affected·Aug 28, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of...
Diagnostic Devices·5,970 affected·Aug 25, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of ...
Cardiac Devices·1,239 affected·Jul 24, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Medical Devices·1,800 affected·Jun 30, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Calibrator
Medical Devices·1,872 affected·Jun 5, 2020
High RiskFDA
Siemens Healthcare Diagnostics Inc
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Medical Devices·436 affected·May 27, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management Sys...
Medical Devices·186 affected·May 15, 2020
High RiskFDA
Siemens Healthcare Diagnostics Inc.
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use i...
Diagnostic Devices·1,555 affected·May 15, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Medical Devices·927 affected·May 7, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quan...
Diabetes Devices·5 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative ...
Medical Devices·1,488 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement ...
Diabetes Devices·26 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative dete...
Medical Devices·8,261 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Medical Devices·1,807 affected·Feb 27, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diag...
Diagnostic Devices·5,666 affected·Feb 13, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Prod...
Diagnostic Devices·1,639 affected·Feb 13, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellic...
Diagnostic Devices·2,323 affected·Feb 13, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (60...
Diagnostic Devices·6,118 affected·Feb 5, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE...
Diagnostic Devices·2,267 affected·Feb 5, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is in...
Diagnostic Devices·2,149 affected·Jan 6, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: T...
Diagnostic Devices·0 affected·Jan 6, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Diagnostic Devices·11,725 affected·Dec 18, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Diagnostic Devices·824 affected·Dec 18, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Diagnostic Devices·2,198 affected·Dec 18, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the ca...
Diagnostic Devices·844 affected·Nov 19, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADV...
Diagnostic Devices·1,306 affected·Nov 19, 2019