Greiner Bio-One North America, Inc.
Greiner Bio-One North America, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2024, with 16 FDA device recalls on record.
Top product codes for Greiner Bio-One North America, Inc.
FDA recalls by Greiner Bio-One North America, Inc.
10 most recent of 16- Z-0571-2026 — Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
- Z-0408-2026 — Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
- Z-2375-2024 — VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
- Z-0733-2024 — VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
- Z-1583-2023 — greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
- Z-0502-2022 — greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
- Z-2507-2021 — Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
- Z-2485-2021 — VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
- Z-1534-2021 — VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
- Z-3027-2020 — VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Greiner Bio-One North America, Inc.
- K233979 — VACUETTE® QUICKSHIELD Complete (Plus)
- K122687 — BLOOD CULTURE HOLDER
- K121908 — SAFETY INFUSION SET
- K113505 — VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
- K103041 — VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
- K102774 — VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
- K081929 — VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
- K072320 — GREINER VACUETTE QUICKSHIELD COMPLETE
- K063357 — MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
- K061483 — VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
Data sourced from openFDA. This site is unofficial and independent of the FDA.