Siemens Healthcare Diagnostics, Inc.
444 recalls on record · Latest: Nov 19, 2025
FDA Devices Moderate Mar 15, 2017
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with th…
FDA Devices Moderate Mar 15, 2017
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the qua…
FDA Devices Moderate Mar 15, 2017
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quan…
FDA Devices Moderate Mar 8, 2017
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …
FDA Devices Moderate Mar 8, 2017
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …
FDA Devices Moderate Mar 8, 2017
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, …
FDA Devices Low Feb 22, 2017
The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For …
FDA Devices Low Feb 22, 2017
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransfer…
FDA Devices Moderate Feb 15, 2017
Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammon…
FDA Devices Moderate Feb 8, 2017
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagno…
FDA Devices Moderate Dec 28, 2016
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog…
FDA Devices Moderate Dec 14, 2016
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
FDA Devices Moderate Nov 30, 2016
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Ch…
FDA Devices Moderate Nov 23, 2016
ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Sie…
FDA Devices Moderate Nov 23, 2016
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_…
FDA Devices Moderate Nov 23, 2016
ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Sie…
FDA Devices Low Nov 23, 2016
Dimension Vista IRON Flex reagent cartridges
FDA Devices Moderate Nov 23, 2016
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
FDA Devices Low Nov 23, 2016
Dimension IRON Flex reagent cartridges
FDA Devices Moderate Nov 23, 2016
Aptio Automation Modules
FDA Devices Moderate Nov 23, 2016
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
FDA Devices Moderate Nov 2, 2016
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique …
FDA Devices Moderate Oct 19, 2016
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/C…
FDA Devices Moderate Oct 19, 2016
ADVIA Centaur XPT Immunoassay System
FDA Devices Moderate Oct 19, 2016
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device…
FDA Devices Moderate Oct 12, 2016
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
FDA Devices Moderate Oct 5, 2016
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl …
FDA Devices Moderate Sep 21, 2016
Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 1032123…
FDA Devices Moderate Sep 21, 2016
RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
FDA Devices Moderate Sep 21, 2016
RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
FDA Devices Moderate Sep 21, 2016
Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
FDA Devices Moderate Sep 14, 2016
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
FDA Devices Moderate Sep 7, 2016
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when …
FDA Devices Low Aug 31, 2016
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use…
FDA Devices Moderate Aug 3, 2016
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human …
FDA Devices Moderate Jun 8, 2016
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lot…
FDA Devices Moderate Jun 8, 2016
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lo…
FDA Devices Moderate May 25, 2016
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of tri…
FDA Devices Moderate May 18, 2016
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of…
FDA Devices Moderate May 18, 2016
Dimension Assays: Triglycerides (TGL)
FDA Devices Moderate May 18, 2016
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
FDA Devices Moderate May 18, 2016
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO metho…
FDA Devices Moderate May 18, 2016
Dimension Assays: ENZYMATIC CREATININE
FDA Devices Moderate May 18, 2016
Dimension Assays: Direct HDL Cholesterol (AHDL)
FDA Devices Moderate May 18, 2016
Dimension Vista Assays: Triglycerides (TRIG)
FDA Devices Moderate May 18, 2016
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
FDA Devices Moderate May 18, 2016
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
FDA Devices Moderate May 18, 2016
Dimension Vista Assays: Uric Acid (URCA)
FDA Devices Moderate May 18, 2016
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
FDA Devices Moderate May 18, 2016