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.
- Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative de…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitativ…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
FDA Device · Class II · 2020-05-06 · Siemens Healthcare Diagnostics - Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic…
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBI…
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TB…
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic u…
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE sy…
FDA Device · Class II · 2020-03-25 · Siemens Healthcare Diagnostics - IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600…
FDA Device · Class II · 2020-03-25 · Siemens Healthcare Diagnostics - Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
FDA Device · Class II · 2020-03-11 · Siemens Healthcare Diagnostics - Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The…
FDA Device · Class II · 2020-03-11 · Siemens Healthcare Diagnostics - Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is inte…
FDA Device · Class II · 2020-03-11 · Siemens Healthcare Diagnostics - ADVIA Chemistry Lipase, Ref
FDA Device · Class II · 2020-03-04 · Siemens Healthcare Diagnostics - Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the cali…
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA…
FDA Device · Class II · 2020-02-26 · Siemens Healthcare Diagnostics - Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automate…
FDA Device · Class II · 2020-02-05 · Siemens Healthcare Diagnostics - Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
FDA Device · Class II · 2020-01-29 · Siemens Healthcare Diagnostics - Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
FDA Device · Class II · 2020-01-29 · Siemens Healthcare Diagnostics - Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
FDA Device · Class II · 2020-01-29 · Siemens Healthcare Diagnostics - Atellica CH 930 Analyzer
FDA Device · Class II · 2019-12-04 · Siemens Healthcare Diagnostics - Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
FDA Device · Class II · 2019-10-30 · Siemens Healthcare Diagnostics - Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
FDA Device · Class II · 2019-10-30 · Siemens Healthcare Diagnostics - Siemens Atellica CH 930 Analyzer
FDA Device · Class II · 2019-10-23 · Siemens Healthcare Diagnostics - Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti…
FDA Device · Class II · 2019-10-02 · Siemens Healthcare Diagnostics - IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
FDA Device · Class II · 2019-08-28 · Siemens Healthcare Diagnostics - IMMULITE 2000 Progesterone
FDA Device · Class II · 2019-08-28 · Siemens Healthcare Diagnostics - N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Sieme…
FDA Device · Class II · 2019-08-28 · Siemens Healthcare Diagnostics - Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dim…
FDA Device · Class II · 2019-08-14 · Siemens Healthcare Diagnostics - Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in hepar…
FDA Device · Class II · 2019-08-07 · Siemens Healthcare Diagnostics - ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Cre…
FDA Device · Class II · 2019-07-10 · Siemens Healthcare Diagnostics - Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatin…
FDA Device · Class II · 2019-07-10 · Siemens Healthcare Diagnostics - Atellica IM 1300 Analyzer, Material Number 11066001
FDA Device · Class II · 2019-05-15 · Siemens Healthcare Diagnostics - Atellica IM 1600 Analyzer, Material Number 11066000
FDA Device · Class II · 2019-05-15 · Siemens Healthcare Diagnostics - Atellica Sample Handler Prime, Material Number 11069001
FDA Device · Class II · 2019-05-15 · Siemens Healthcare Diagnostics - Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
FDA Device · Class II · 2019-05-08 · Siemens Healthcare Diagnostics - SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
FDA Device · Class II · 2019-05-08 · Siemens Healthcare Diagnostics - Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
FDA Device · Class II · 2019-05-08 · Siemens Healthcare Diagnostics - Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
FDA Device · Class II · 2019-05-08 · Siemens Healthcare Diagnostics - syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with…
FDA Device · Class II · 2019-04-24 · Siemens Healthcare Diagnostics - Dimension Vista 500, Analyzer, chemistry Model no. 10284473
FDA Device · Class II · 2019-03-27 · Siemens Healthcare Diagnostics - Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
FDA Device · Class II · 2019-03-27 · Siemens Healthcare Diagnostics - Atellica IM 1300 Analyzer
FDA Device · Class II · 2019-02-06 · Siemens Healthcare Diagnostics