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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.
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative me...
Diagnostic Devices·18,668 affected·Feb 16, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability Th...
Diagnostic Devices·394 affected·Feb 9, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS ...
Medical Devices·1,895 affected·Jan 14, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS REC...
Medical Devices·1,680 affected·Jan 14, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 ...
Diagnostic Devices·9,334 affected·Jan 13, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diag...
Diagnostic Devices·33,604 affected·Jan 13, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For i...
Diagnostic Devices·9,251 affected·Jan 13, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagno...
Diagnostic Devices·1,945 affected·Jan 13, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qua...
Diagnostic Devices·52 affected·Nov 19, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS an...
Diagnostic Devices·78 affected·Nov 11, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catal...
Diagnostic Devices·146 affected·Nov 11, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
Diagnostic Devices·2,647 affected·Nov 11, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
Diagnostic Devices·192 affected·Nov 11, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Num...
Diagnostic Devices·608 affected·Nov 11, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc.
Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use wi...
Diagnostic Devices·4 affected·Nov 10, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA ...
Diagnostic Devices·1,637 affected·Nov 3, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine,...
Medical Devices·87 affected·Oct 7, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in...
Diagnostic Devices·3,601 affected·Sep 30, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions wi...
Diagnostic Devices·449 affected·Aug 26, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is d...
Diabetes Devices·2,079 affected·Aug 24, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is d...
Diabetes Devices·49 affected·Aug 24, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ...
Diagnostic Devices·466 affected·Jul 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for...
Diagnostic Devices·1,655 affected·Jul 23, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is...
Diagnostic Devices·32,165 affected·Jul 15, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and...
Diagnostic Devices·1,032 affected·Jun 30, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab aut...
Medical Devices·1,941 affected·May 19, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in...
Medical Devices·2,713 affected·May 6, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. Fo...
Diagnostic Devices·17 affected·May 6, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and pos...
Medical Devices·1,355 affected·Apr 29, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in ...
Medical Devices·155 affected·Apr 9, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dime...
Diagnostic Devices·17,801 affected·Apr 2, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activ...
Diagnostic Devices·27,501 affected·Mar 25, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Diagnostic Devices·7,814 affected·Mar 23, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Diagnostic Devices·9,778 affected·Jan 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Diagnostic Devices·1,719 affected·Jan 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Diagnostic Devices·11,980 affected·Jan 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plast...
Medical Devices·32,384 affected·Jan 22, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic c...
Medical Devices·6,184 affected·Jan 22, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_...
Diagnostic Devices·657 affected·Jan 19, 2015
RecallFDA
Siemens Healthcare Diagnostics, Inc.
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/s...
Diagnostic Devices·26 affected·Jan 15, 2015
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. The RAPIDPoint 500 system is desi...
Diabetes Devices·4,376 affected·Dec 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diag...
Diabetes Devices·2,863 affected·Dec 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diag...
Diabetes Devices·241 affected·Dec 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software ...
Medical Devices·7 affected·Dec 16, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobi...
Diagnostic Devices·1,230 affected·Nov 24, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to ...
Diagnostic Devices·1,949 affected·Nov 5, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as a...
Diagnostic Devices·3,622 affected·Oct 27, 2014
RecallFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULI...
Diagnostic Devices·2,212 affected·Oct 20, 2014