Greiner Bio-One North America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
10
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0571-2026Class IIBrand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 4August 19, 2025
Z-0408-2026Class IIGreiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322August 8, 2025
Z-2375-2024Class IIVACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridgedMay 14, 2024
Z-0733-2024Class IIVACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, noDecember 12, 2023
Z-1583-2023Class IIgreiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 5March 31, 2023
Z-0502-2022Class IIgreiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridgedDecember 9, 2021
Z-2507-2021Class IIGreiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sAugust 20, 2021
Z-2485-2021Class IIVACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridgedAugust 13, 2021
Z-1534-2021Class IIVACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwMarch 29, 2021
Z-3027-2020Class IIVACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are useAugust 28, 2020
Z-1714-2020Class IIVACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.March 12, 2020
Z-0818-2020Class IIVACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, HoldNovember 25, 2019
Z-1923-2016Class II4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contApril 26, 2016
Z-0835-2013Class IIVACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item nuFebruary 1, 2013
Z-2154-2012Class II3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 CapJuly 2, 2012
Z-1935-2012Class IIVacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield ComApril 2, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K233979VACUETTE® QUICKSHIELD Complete (Plus)July 19, 2024
K122687BLOOD CULTURE HOLDERJanuary 10, 2013
K121908SAFETY INFUSION SETJuly 25, 2012
K113505VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDERFebruary 17, 2012
K103041VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATORNovember 9, 2010
K102774VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDEROctober 15, 2010
K081929VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATORDecember 16, 2008
K072320GREINER VACUETTE QUICKSHIELD COMPLETESeptember 14, 2007
K063357MINICOLLECT CAPILLARY BLOOD COLLECTION TUBESJuly 10, 2007
K061483VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLESAugust 14, 2006