Siemens Healthcare Diagnostics, Inc.
Newark, DE
This page shows every FDA and USDA recall linked to Siemens Healthcare Diagnostics, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
221
Total Recalls
2007
First Recall
2024
Most Recent
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Dec 26, 2024
· Device
Open, Classified
Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Sep 6, 2024
· Device
Open, Classified
Aptio Automation Storage and Retrieval Module (SRM)
Jul 5, 2023
· Device
Open, Classified
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD
Siemens Material Numbe...
Oct 14, 2022
· Device
Open, Classified
Dimension Magnesium (MG) Flex reagent cartridge
Siemens
Material Number (SMN)/REF (Catalog Number):10444963/DF...
Sep 26, 2022
· Device
Open, Classified
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of...
Aug 29, 2022
· Device
Open, Classified
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human se...
Jul 6, 2022
· Device
Terminated
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human s...
Jul 6, 2022
· Device
Terminated
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in th...
Jan 28, 2022
· Device
Open, Classified
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pip...
Oct 15, 2021
· Device
Terminated
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pip...
Oct 15, 2021
· Device
Terminated
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CE...
Oct 6, 2021
· Device
Open, Classified
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of l...
Feb 3, 2021
· Device
Open, Classified
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the...
Oct 20, 2020
· Device
Terminated
Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the
q...
Aug 19, 2020
· Device
Terminated
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the q...
Jul 24, 2020
· Device
Terminated
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 -
HC0015BZZWW external accessory to DCA V...
Jun 30, 2020
· Device
Terminated
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Us...
Jun 5, 2020
· Device
Terminated
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product...
Jun 5, 2020
· Device
Terminated
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usag...
Jun 5, 2020
· Device
Terminated
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in th...
Jun 5, 2020
· Device
Terminated
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Pro...
Jun 5, 2020
· Device
Terminated
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: u...
Jun 5, 2020
· Device
Terminated
ADVIA Chemistry Total Bilirubin_2 assay-
SMN: 10341115 (40 mL) & 10341113 (70 mL).
Product Usage: ADVIA TBI...
Feb 13, 2020
· Device
Terminated
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin
SMN: 1109753...
Feb 13, 2020
· Device
Terminated
Dimension Vista Total Bilirubin Flex reagent cartridge
-In vitro Diagnostic for the determination of total b...
Feb 13, 2020
· Device
Terminated
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL...
Feb 13, 2020
· Device
Terminated
Dimension Total Bilirubin Flex reagent cartridge
-In vitro Diagnostic for the determination of total bilirubi...
Feb 13, 2020
· Device
Terminated
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin
SMN: 110975...
Feb 13, 2020
· Device
Terminated
Dimension Ferritin (FERR) Flex reagent cartridge
DM FERR
Product Usage:
The FERR Flex reagent cartridge is in...
Jul 15, 2019
· Device
Terminated
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage:...
May 3, 2019
· Device
Terminated
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Us...
May 3, 2019
· Device
Terminated
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
Dec 12, 2018
· Device
Terminated
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
Dec 12, 2018
· Device
Terminated
Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical...
Oct 16, 2018
· Device
Terminated
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical...
Oct 16, 2018
· Device
Terminated
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quanti...
Oct 11, 2018
· Device
Terminated
Dimension Thermal Chamber Motor Cable located in the following models:
Model/UDI Number:
Dimension EXL 200 006...
Sep 28, 2018
· Device
Terminated
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277
Product Usage:
Dimension - The LIPL method is...
Sep 7, 2018
· Device
Terminated
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745
Product Usage:
Dimension Vista - The LIP...
Sep 7, 2018
· Device
Terminated
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306
Device is point-of-care system for...
Jul 16, 2018
· Device
Terminated
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055,
10321238, 10322...
Jul 16, 2018
· Device
Terminated
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395
Device is point-of-care system for comprehen...
Jul 16, 2018
· Device
Terminated
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393
Device is point-of-care system for comprehens...
Jul 16, 2018
· Device
Terminated
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are...
Apr 19, 2018
· Device
Terminated
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are...
Apr 19, 2018
· Device
Terminated
Dimension Vista System LOCI 8 CALIBRATOR
The LOCI 8 Calibrator is an in vitro diagnostic product for the cal...
Mar 26, 2018
· Device
Terminated
Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586
Mar 21, 2018
· Device
Terminated
Dimension Vista MULTI 1 SDIL, KD693, SMN# 10469971
Mar 21, 2018
· Device
Terminated
Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205
Mar 21, 2018
· Device
Terminated