The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Additional information regarding the possibility of obtaining over-estimated results of Androstendione with the IMMULITE / IMMULITE 1000 systems, manufactured by Siemens Healthcare Diagnostics Products Limited, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Withdrawal from the market of certain batches of the IMMULITE® / IMMULITE® 1000 Cortisol kit (LKCO1), manufactured by Siemens Healthcare Diagnostics Products Limited, United Kingdom, because they show a positive deviation in the results.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Incorrect expiration date in the Instructions for Use (IFU) of the Control Module of IMMULITE® Calcitonin, lot 0019 manufactured by Siemens Healthcare Diagnostics Products Limited, United Kingdom
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Positive bias in the controls of BioRad Lyphochek® Tumor Marker Plus and Liquichek ™ Tumor Marker, with certain batches of the IMMULITE® 2000 / IMMULITE® 2000 XPi GI-MA kit (CA 19-9), manufactured by Siemens Healthcare Diagnostics Products Limited, UK
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Increase in incubation time when using batch 055 of the pretreatment solution (LGFA) included in the lot of kit 411 of IGF-I (Insulin-I growth factor) in the IMMULITE / IMMULITE 1000 Systems, manufactured by Siemens Healthcare Diagnostics Products Limited, United Kingdom.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Cessation of the use of certain references and batches of the Rubella IgM Kits, manufactured by Siemens Healthcare Diagnostics Products Limited, UK, because they may present an increase in imprecision in some patient samples.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Cessation of the use of certain references and batches of the CMV IgM kits, manufactured by Siemens Healthcare Diagnostics Products Limited, UK, because they may present an increase in imprecision in some patient samples.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Cessation of the use of batch 408 of the reagent "IMMULITE®2000 / IMMULITE 2000 XPi PSA", manufactured by Siemens Healthcare Diagnostics Products Limited, United Kingdom, due to the identification of a negative bias in patient samples and / or quality controls.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
The IMMULITE PSA tests, manufactured by Siemens Healthcare Diagnostics Products Limited, UK, do not meet the expectations of hook effect at high concentrations indicated in the instructions for use, which may result in falsely low concentrations of PSA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Cessation of the use of lot 320 of the IMMULITE® 2000 / IMMULITE® 2000 XPi Intractable Parathyroid Hormone (iPTH) kit, manufactured by Siemens Healthcare Diagnostics Products Limited, United Kingdom, due to the possibility of presenting a negative deviation in patient samples.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Cessation of the use of certain batches of the product IMMULITE® / IMMULITE® 1000 PSA 3rd Generation, manufactured by Siemens Healthcare Diagnostics Products Limited, United Kingdom, due to the possibility of a negative bias in the results of quality control samples and of patients.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Singapore.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Stability less than 30 days indicated in the instructions for use of lots 124 and 125 of the Sex Hormone Transport Globulin (SHBG) adjuster for the IMMULITE 2000 / IMMULITE 2000 XPi systems, manufactured by Siemens Healthcare Diagnostics Products Limited, UK, reconstitute them and keep them at 2-8 ºC.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possibility of invalid settings with batch 328 of the "Folic Acid Reagent Kit for IMMULITE® and IMMULITE® 1000 analyzers", Reference LKFO1, manufactured by Siemens Healthcare Diagnostics Products Limited, United Kingdom
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possibility of obtaining over-estimated results in patient samples with the IMMULITE / IMMULITE 1000 Androstenedione and IMMULITE 2000 / IMMULITE 2000 XPi Androstenedione assays, manufactured by Siemens Healthcare Diagnostics Products Ltd.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possible dropping of the cover of the ADVIA Centaur XP Immunoassay System, manufactured by Siemens Healthcare Diagnostics SL, United States, due to the wear of the hydraulic spring that holds the cover.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possible failure of the access door hinge of the MicroScan WalkAway 40 Plus and WalkAway-96 Plus systems, manufactured by Siemens Healthcare Diagnostics SL, United States.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Low recovery of magnesium (MG) in the quality control (QC) and in the samples of the patients after the calibration of the MG with the batch 3GM081 of the chemical calibrator 1, reference KC110, manufactured by Siemens Healthcare Diagnostics SL, States
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possibility that certain programmers of tasks of the CentraLink ™ Computer System version 14, manufactured by Siemens Healthcare Diagnostics SL, USA, stop executing commands, including the sending of validated results to the LIS.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Error in the Confirmatory card of the ADVIA Centaur Confirmatory trial included in certain batches of the ADVIA Centaur HBsAgII kits, manufactured by Siemens Healthcare Diagnostics SL, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possibility that certain cartridges of ADVIA Centaur® BPN ReadyPacks primary reagent from batch 038174, manufactured by Siemens Healthcare Diagnostics SL, USA, have an incorrect side label.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possibility that in the Systems ADVIA Química XPT, with software version 1.0.2, manufactured by Siemens Healthcare Diagnostics SL, USA, the samples remain in the status of "In process".
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Withdrawal from the market of certain batches of the reagent "Berichrom® Heparin", catalog No. OWLD11, SMN 10446620, manufactured by Siemens Healthcare Diagnostics, Germany, due to the possibility of having a reduced on-board stability.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Change in the concentration of N-Acetylcysteine (NAC) that can cause interference in the acetaminophen assay, in the systems ADVIA Chemistry 1200, 1800, 2400 and ADVIA Chemistry XPT, manufactured by Siemens Healthcare Diagnostics, USA
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Notas adicionales en la data
Acción
Possibility that when using the EasyLink ™ Computer System, version 5.0, manufactured by Siemens Healthcare Diagnostics, Inc., the results of Quality Control (CC) can be unexpectedly associated with a Pending Control.