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 the footrest of certain models and serial numbers of the X-ray systems, manufactured by Villa Sistemi Medicali SpA, Italy.
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, if the operator exceeds the support arm of the board to move a patient from the tables of the Apollo Systems, Apollo DRF, Apollo EZ, Apollo EZ DRF, and Juno DRF, manufactured by Villa Sistemi Medicali, SpA, Italy , be imprisoned by the team.
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
Removal from the market of certain references and batches of the microperfusion "Microflex", manufactured by Vygon, France.
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 lot 050914AC of the "spinal needle", reference 181.052, manufactured by Vygon SA, France, because some units could contain a 22G introducer needle instead of 20G.
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
Removal from the market of certain batches of kits of 10 and 25 tests of IIb / IIIa VeryNow, manufactured by Accumetrics Inc, USA, due to the possibility that they generate an erroneously low result of platelet aggregation units (PAU).
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 an error in the identification of samples in the TOP Family analyzers, manufactured by Instrumentation Laboratory Co, 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 of a performance anomaly in certain vials of lots of HemosIL PT-Fibrinogen HS PLUS, manufactured by Instrumentation Laboratory Co, USA, which could cause a significant variation in INR values.
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
Software update to version v2.2.2 of the "ACLUS ACL Analyzer", model 0009801000, manufactured by Instrumentation Laboratory Co, USA, due to the possibility that the previous version may give erroneously low 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
Removal from the market of certain batches of the HemosIL von Willebrand Factor Activity reagent, manufactured by Instrumentation Laboratory Co., USA, due to the possibility of positive deviations 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
Re-titling of Target Values and Acceptance Ranges for certain batches of calibrator and control currently on the market necessary for the use of HemosIL von Willebrand Factor Activity reagent, manufactured by Instrumentation Laboratory Co.
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 Hemosil Synthasil reagent, manufactured by Instrumentation Laboratory Co., USA, in systems of the ACL TOP family, there will be a drag between reagents that causes a shortening in the coagulation times of TTPA
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 batch B22585 of the HemosIL AcuStar HIT-Ab reagent (PF4-H), manufactured by Instrumentation Laboratory, Co., 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
Withdrawal from the market of lots B23198, B23445 and B23605 of HemosIL AcuStar reagent HIT-Ab (PF4-H), manufactured by Instrumentation Laboratory, Co., 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
Withdrawal from the market of certain batches of the product "ProTime3® Buckets, Codes PRO3-25 and PRO3-50", manufactured by International Technidyne Corporation, USA, because the results of INR may be lower than expected.
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
Removal from the market of certain references and batches of the elastomeric infusion pump "Dosifuser", manufactured by Leventon SAU, Spain, due to the possibility of capillary seizure and infusion being interrupted.
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
Inclusion of new warnings in the instructions for use of the ROTEM® sigma complete + hep cartridge, reference 555502, manufactured by TEM Innovations GmbH, Germany.
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 21734044 of the r ex-tem® reagent, manufactured by TEM Innovations GmbH, Germany, due to the possibility of obtaining coagulation time values longer than expected.
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 batch market 24723031 of the product Alegria® Anti-Intrinsic Factor, reference ORG 247-24, manufactured by Orgentec Diagnostika GmbH, Germany, due to the possibility of obtaining false negatives.
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 use of certain batches of the product Alegria® Anti-Intrinsic Factor, reference ORG 247, manufactured by Orgentec Diagnostika GmbH, Germany, due to the possibility of obtaining false negative 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
Cessation of the use and recall of lot 1603703 of the Anti-beta-2-glycoprotein I IgG assay kit, manufactured by Orgentec Diagnostika GmbH, Germany, due to the possibility of obtaining high and false positive 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
Cessation of the use of batch 1612319 of the "kit anti intrinsic factor alegria", reference ORG 247, and batch 1612153 of the "Kit anti-mycoplasma pneumoniae IGM ABS", reference ORG 915MX, manufactured by ORGENTEC Diagnostika GmbH, Germany, due to a possible defect in the sealing of the container of the strips.
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 the locking system of the internal cannula in the external cannula of the TRACOE twist and TRACOE experc set twist systems, manufactured by TRACOE medical GmbH, between December 2012 and June 2013, is too tight or too tight.
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
Removal from the market of certain batches of the Certain 3mm Low Profile dental abutment, ILPAC3217, manufactured by Biomet 3i, United States, because some containers may contain the 5mm abutment, ILPAC5217
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 some packages of the lots 2010100001, 2010080684 and 2010090191 of the product LPCCC1, calcined hexagonal cylinder, manufactured by Biomet 3i, USA, contain the product LPCCC2, rotary cylinder castable.
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 lot 2011090751 of the product Osseotite® Tapered Certain® Implant, manufactured by Biomet 3i, USA, due to the possibility of not having an internal thread.