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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.
syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siem...
Medical Devices·262 affected·May 10, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormon...
Diagnostic Devices·33,506 affected·May 10, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the...
Medical Devices·17,719 affected·May 6, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure ...
Diagnostic Devices·13,751 affected·Apr 25, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglo...
Diabetes Devices·11,006 affected·Apr 22, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Diagnostic Devices·3,871 affected·Mar 13, 2013
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
Medical Devices·2,207 affected·Feb 27, 2013
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
Medical Devices·2,207 affected·Feb 27, 2013
RecallFDA
Siemens Healthcare Diagnostics Inc
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Medical Devices·1 affected·Feb 26, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Flui...
Diagnostic Devices·3,395 affected·Dec 19, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended...
Diagnostic Devices·1,979 affected·Dec 10, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the ...
Diagnostic Devices·1,998 affected·Dec 6, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Diagnostic Devices·2,976 affected·Nov 27, 2012
RecallFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Contr...
Diabetes Devices·7,865 affected·Nov 21, 2012
RecallFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Ch...
Diabetes Devices·325 affected·Nov 21, 2012
RecallFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ P...
Diabetes Devices·700 affected·Nov 21, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine ...
Diabetes Devices·1,130 affected·Nov 21, 2012
RecallFDA
Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with...
Diabetes Devices·16,711 affected·Nov 21, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 ...
Diagnostic Devices·100 affected·Nov 14, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro...
Diagnostic Devices·50 affected·Nov 14, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in v...
Diagnostic Devices·250 affected·Nov 14, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinic...
Medical Devices·317 affected·Oct 11, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of ...
Diagnostic Devices·1,985 affected·Oct 10, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalo...
Diagnostic Devices·234 affected·Oct 9, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Cata...
Diagnostic Devices·2,440 affected·Oct 9, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determin...
Diagnostic Devices·19,310 affected·Oct 8, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for i...
Diabetes Devices·2,939 affected·Sep 17, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing...
Diabetes Devices·4,494 affected·Sep 17, 2012
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for pro...
Diabetes Devices·2,152 affected·Sep 17, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marke...
Diagnostic Devices·15,455 affected·Sep 11, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pac...
Diagnostic Devices·15 affected·Aug 7, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phe...
Diagnostic Devices·79,744 affected·Jul 30, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the AD...
Diagnostic Devices·2 affected·Jul 25, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (...
Diagnostic Devices·2,050 affected·Jul 17, 2012
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzer...
Diagnostic Devices·2,554 affected·Jul 17, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in hum...
Diagnostic Devices·1,894 affected·Jul 17, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-d...
Diagnostic Devices·786 affected·Jun 7, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic ...
Diagnostic Devices·637 affected·May 29, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista Syste...
Diagnostic Devices·59,735 affected·May 8, 2012