Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Sepa... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Sepa... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Cat... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Cat... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Sep... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Se... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/C... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtu... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Mo... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 01... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Cata... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Descripti... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog... Sep 26, 2025 FDA device enforcement
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II Reported ongoing
Distribution: Distribution US nationwide and Canada.
Official source for SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catal...