Siemens Healthcare Diagnostics, Inc.
444 recalls on record · Latest: Nov 19, 2025
FDA Devices Moderate May 18, 2016
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
FDA Devices Moderate Apr 27, 2016
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hemat…
FDA Devices Moderate Mar 30, 2016
IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product U…
FDA Devices Moderate Mar 30, 2016
Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use i…
FDA Devices Moderate Mar 30, 2016
IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diag…
FDA Devices Moderate Mar 30, 2016
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test fo…
FDA Devices Moderate Mar 16, 2016
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro…
FDA Devices Moderate Mar 9, 2016
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usag…
FDA Devices Moderate Mar 2, 2016
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, C…
FDA Devices Moderate Mar 2, 2016
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED),…
FDA Devices Moderate Feb 10, 2016
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral…
FDA Devices Moderate Jan 13, 2016
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Cata…
FDA Devices Moderate Jan 13, 2016
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: C…
FDA Devices Moderate Jan 13, 2016
Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
FDA Devices Moderate Jan 13, 2016
Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
FDA Devices Moderate Jan 13, 2016
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO S…
FDA Devices Moderate Jan 13, 2016
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in …
FDA Devices Moderate Dec 30, 2015
Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimen…
FDA Devices Moderate Dec 30, 2015
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and…
FDA Devices Moderate Dec 2, 2015
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum…
FDA Devices Moderate Sep 30, 2015
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for …
FDA Devices Moderate Sep 30, 2015
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for …
FDA Devices Moderate Sep 16, 2015
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro…
FDA Devices Moderate Sep 16, 2015
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centau…
FDA Devices Moderate Sep 2, 2015
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantit…
FDA Devices Moderate Aug 26, 2015
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lit…
FDA Devices Moderate Jul 8, 2015
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic f…
FDA Devices Moderate Jul 8, 2015
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation syst…
FDA Devices Moderate Jul 8, 2015
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, v…
FDA Devices Moderate Jul 1, 2015
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro d…
FDA Devices Moderate Jun 10, 2015
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial…
FDA Devices Moderate Jun 10, 2015
Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation fa…
FDA Devices Moderate May 27, 2015
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosi…
FDA Devices Moderate May 20, 2015
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand …
FDA Devices Moderate Apr 29, 2015
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
FDA Devices Moderate Apr 1, 2015
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theo…
FDA Devices Low Mar 25, 2015
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples…
FDA Devices Moderate Mar 18, 2015
RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. The RAPIDPoint 500 system is designed for pro…
FDA Devices Moderate Mar 18, 2015
Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plastic capillari…
FDA Devices Moderate Mar 18, 2015
RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diagnostic use b…
FDA Devices Moderate Mar 18, 2015
Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries …
FDA Devices Moderate Mar 18, 2015
RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diagnostic use b…
FDA Devices Moderate Mar 11, 2015
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
FDA Devices Moderate Mar 11, 2015
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
FDA Devices Moderate Mar 11, 2015
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
FDA Devices Moderate Jan 21, 2015
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network…
FDA Devices Moderate Jan 14, 2015
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) meth…
FDA Devices Moderate Dec 31, 2014
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
FDA Devices Moderate Dec 31, 2014
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate ma…
FDA Devices Moderate Dec 31, 2014