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VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

FDA Recall
Open, Classified ·bioMerieux, Inc.·Product code LON·June 26, 2025

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

FDA Recall
Open, Classified ·GN Otometrics Horskatten 9 Taastrup Denmark·Product code DSA·August 1, 2019

VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

FDA Recall
Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGN·July 12, 2018

Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

FDA Recall
Open, Classified ·Accriva Diagnostics, Inc.·Product code GGN·April 30, 2026

Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code CGN·July 3, 2024