Company · US
Greiner Bio-One North America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2024. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
26recalls (2 in 12 months)
26recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 2024 | K233979 | VACUETTE® QUICKSHIELD Complete (Plus) Greiner Bio-One North America, Inc. | JKA |
| Jan 10, 2013 | K122687 | BLOOD CULTURE HOLDER Greiner Bio-One North America, Inc. | JKA |
| Jul 25, 2012 | K121908 | SAFETY INFUSION SET Greiner Bio-One North America, Inc. | FMI |
| Feb 17, 2012 | K113505 | VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER Greiner Bio-One North America, Inc. | FMI |
| Nov 9, 2010 | K103041 | VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR Greiner Bio-One North America, Inc. | JKA |
| Oct 15, 2010 | K102774 | VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER Greiner Bio-One North America, Inc. | FMI |
| Dec 16, 2008 | K081929 | VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR Greiner Bio-One North America, Inc. | JKA |
| Sep 14, 2007 | K072320 | GREINER VACUETTE QUICKSHIELD COMPLETE Greiner Bio-One North America, Inc. | FMI |
| Jul 10, 2007 | K063357 | MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES Greiner Bio-One North America, Inc. | JKA |
| Aug 14, 2006 | K061483 | VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES Greiner Bio-One North America, Inc. | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2026 | Greiner Bio-One North America, Inc. Brand Name: VACUETTE
Product Name: LH Lithium Heparin Separator
Model/Catalog Number: 454008P
Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 7 Open, Classified |
JKA | K960857 |
| Nov 19, 2025 | Greiner Bio-One North America, Inc. 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 Separat Open, Classified |
JKA | K081929 K983952 |
| Oct 28, 2025 | Greiner Bio-One North America, Inc. Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 Open, Classified |
GIM | K971221 |
| Jul 17, 2024 | Greiner Bio-One North America, Inc. VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100
red cap-yellow ring, non-ridged Open, Classified |
JKA | K081929 K960858 +1 |
| Jan 16, 2024 | Greiner Bio-One North America, Inc. VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged. Open, Classified |
JKA | K971239 |
| May 12, 2023 | Greiner Bio-One North America, Inc. 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 Completed |
JKA | K960860 |
| Dec 9, 2021 | Greiner Bio-One North America, Inc. 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 Terminated |
JKA | K960857 |
| Aug 20, 2021 | Greiner Bio-One North America, Inc. Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged Terminated |
GIM | K971221 |
| Aug 13, 2021 | Greiner Bio-One North America, Inc. VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged Terminated |
JKA | K971236 |
| May 6, 2021 | Greiner Bio-One North America, Inc. 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 Terminated |
GIM | K971221 |
| Aug 28, 2020 | Greiner Bio-One North America, Inc. 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 Terminated |
JKA | K081929 |
| Mar 12, 2020 | Greiner Bio-One North America, Inc. VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355. Terminated |
GIM | K971221 |
| Nov 25, 2019 | Greiner Bio-One North America, Inc. VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are Terminated |
JKA | K983952 |
| Apr 26, 2016 | Greiner Bio-One North America, Inc. 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297
VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is Terminated |
JKA | K971239 |
| Feb 15, 2013 | Greiner Bio-One North America, Inc. VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures. Terminated |
FMI | K011786 |
| Aug 7, 2012 | Greiner Bio-One North America, Inc. 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334,
Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110.
Intended Use: Venous blood collection tubes. Terminated |
GIM | K971221 |
| Jul 3, 2012 | Greiner Bio-One North America, Inc. Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one.
The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine veni Terminated |
FMI | K072320 |
| Feb 22, 2012 | Greiner Bio-One North America, Inc. LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110.
Venous blood collection tubes. Terminated |
JKA | K960857 |
| Nov 14, 2011 | Greiner Bio-One North America, Inc. Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209. Terminated |
JKA | K971236 |
| Nov 9, 2011 | Greiner Bio-One North America, Inc. Quick Shield with Snappy Safety Holder, Greiner bio-one.
The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Col Terminated |
FMI | K102774 |
| Aug 8, 2011 | Greiner Bio-One North America, Inc. HOLDEX Single-Use Holder PP closed pack.
Greiner Bio-One Austria Gmbh.
A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless stee Terminated |
FMI | K980768 |
| Dec 16, 2010 | Greiner Bio-One North America, Inc. Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC.
Venous blood collection tubes. Terminated |
JKA | K960857 |
| Nov 7, 2008 | Greiner Bio-One North America, Inc. VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bi Terminated |
JKA | K960857 |
| Sep 30, 2008 | Greiner Bio-One North America, Inc. Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports. Terminated |
FMI | K980768 |
| Sep 11, 2008 | Greiner Bio-One North America, Inc. Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the Terminated |
FMI | K980768 |
| Sep 13, 2006 | Greiner Bio-One North America, Inc. Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Ste Terminated |
GIM | K971221 |