Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There have been reports of stent migration.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
DiaSorin Molecular
Class I - Dangerous
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
Class I - Dangerous
Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Siemens Medical Solutions USA
Class I - Dangerous
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
VIDAS RUB IgG (RBG), REF 30226
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
VIDAS FSH, REF 30407-01
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Class I - Dangerous
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
VIDAS SARS-COV-2 IgM, Ref 423833-01
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Class I - Dangerous
Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property
VIDAS Estradiol II, REF 30431-01
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Atellica CH Âŋ2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of Âŋ2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
Siemens Healthcare Diagnostics
Class I - Dangerous
Âŋ2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
VIDAS Lyme IgG II (LYM), REF 417401
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Class I - Dangerous
Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.
VIDAS PRG Progesterone, REF 30409-01
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
VIDAS LH, REF 30406-01
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
VIDAS Measles IgG (MSG), REF 30219
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
VIDAS Lyme IgM II (LYM), REF 416436
bioMerieux
Class I - Dangerous
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.