Siemens Healthcare Diagnostics recalls
Siemens Healthcare Diagnostics appears in 694 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chem…
FDA Device · Class II · 2013-04-10 · Siemens Healthcare Diagnostics - Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377)
FDA Device · Class III · 2013-04-10 · Siemens Healthcare Diagnostics - Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890)
FDA Device · Class III · 2013-04-10 · Siemens Healthcare Diagnostics - Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the A…
FDA Device · Class III · 2013-04-03 · Siemens Healthcare Diagnostics - Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107)
FDA Device · Class II · 2013-03-27 · Siemens Healthcare Diagnostics - Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge
FDA Device · Class III · 2013-03-20 · Siemens Healthcare Diagnostics - Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010
FDA Device · Class III · 2013-02-06 · Siemens Healthcare Diagnostics - Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for…
FDA Device · Class II · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemen…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Immunoradiometric assay
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Immunoradiometric assay
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Immunoradiometric assay
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistr…
FDA Device · Class II · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: Wh…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Str…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Aut…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistr…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitr…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Cent…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quanti…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Int…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - 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 vitro imm…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination…
FDA Device · Class II · 2012-12-12 · Siemens Healthcare Diagnostics - Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for t…
FDA Device · Class II · 2012-11-28 · Siemens Healthcare Diagnostics - Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of t…
FDA Device · Class III · 2012-11-14 · Siemens Healthcare Diagnostics - Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests)
FDA Device · Class II · 2012-11-07 · Siemens Healthcare Diagnostics - Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobar…
FDA Device · Class II · 2012-10-17 · Siemens Healthcare Diagnostics - ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number
FDA Device · Class III · 2012-09-26 · Siemens Healthcare Diagnostics - ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577…
FDA Device · Class III · 2012-09-26 · Siemens Healthcare Diagnostics - Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVI…
FDA Device · Class II · 2012-09-12 · Siemens Healthcare Diagnostics - syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions
FDA Device · Class II · 2012-09-12 · Siemens Healthcare Diagnostics - Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer…
FDA Device · Class III · 2012-09-05 · Siemens Healthcare Diagnostics - EasyLink Informatic System is included with the Dimension Vista System
FDA Device · Class II · 2012-08-29 · Siemens Healthcare Diagnostics - Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) ass…
FDA Device · Class II · 2012-08-29 · Siemens Healthcare Diagnostics - Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086)
FDA Device · Class III · 2012-08-15 · Siemens Healthcare Diagnostics - Siemens syngo(R) Lab Data Manager
FDA Device · Class II · 2012-08-15 · Siemens Healthcare Diagnostics - EasyLink(TM) Informatics System, Part Number 1000034805
FDA Device · Class II · 2012-08-15 · Siemens Healthcare Diagnostics - Dimension(R) Reagent Management System (RMS) - Power Cord
FDA Device · Class II · 2012-08-15 · Siemens Healthcare Diagnostics - Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for…
FDA Device · Class II · 2012-07-04 · Siemens Healthcare Diagnostics - BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
FDA Device · Class II · 2012-07-04 · Siemens Healthcare Diagnostics