Brand

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
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed f...
Medical Devices·2,239 affected·Oct 17, 2014
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification ...
Medical Devices·1,381 affected·Oct 17, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Diagnostic Devices·10,515 affected·Oct 9, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Diagnostic Devices·10,515 affected·Oct 9, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry...
Diabetes Devices·53 affected·Sep 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro di...
Diagnostic Devices·1,733 affected·Sep 24, 2014
RecallFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems...
Diagnostic Devices·4,645 affected·Sep 12, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and mu...
Medical Devices·858 affected·Aug 19, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA),...
Diabetes Devices·9,769 affected·Aug 18, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body flu...
Diagnostic Devices·2,757 affected·Jul 16, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc...
Diagnostic Devices·40 affected·Jun 2, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Num...
Diagnostic Devices·3,839 affected·Jun 2, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Diagnostic Devices·34,283 affected·May 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; R...
Medical Devices·20,507 affected·May 23, 2014
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, us...
Diagnostic Devices·4 affected·Apr 14, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitativ...
Diagnostic Devices·40,266 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative ...
Diagnostic Devices·12,787 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the...
Diagnostic Devices·155,345 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Medical Devices·16,302 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the ...
Diagnostic Devices·22,770 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN...
Diagnostic Devices·49,123 affected·Mar 25, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine ...
Cardiac Devices·4,175 affected·Mar 19, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determinati...
Diagnostic Devices·1,294 affected·Dec 18, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determinat...
Diagnostic Devices·1,294 affected·Dec 18, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CS...
Cardiac Devices·1,586 affected·Dec 5, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower Us...
Diagnostic Devices·2,038 affected·Oct 7, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measur...
Diagnostic Devices·302 affected·Sep 18, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for ...
Cardiac Devices·1,625 affected·Sep 17, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Nega...
Medical Devices·522 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negati...
Medical Devices·1,324 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (N...
Medical Devices·4,319 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus ...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroSc...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ R...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) -...
Medical Devices·2,158 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negati...
Medical Devices·1,209 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus...
Medical Devices·57,600 affected·Aug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids ...
Medical Devices·57,600 affected·Aug 21, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of fol...
Diagnostic Devices·44 affected·Jul 25, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in...
Diagnostic Devices·2,840 affected·Jul 25, 2013
RecallFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating th...
Diagnostic Devices·265 affected·Jun 28, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnost...
Diagnostic Devices·7,470 affected·Jun 5, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. ...
Diagnostic Devices·776 affected·May 20, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Diagnostic Devices·198 affected·May 14, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determ...
Diagnostic Devices·3,302 affected·May 14, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Diagnostic Devices·99 affected·May 14, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measu...
Medical Devices·51,792 affected·May 10, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to qu...
Medical Devices·172,913 affected·May 10, 2013