ClearanceBrief
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

CodeDeviceRecords
JKATubes, Vials, Systems, Serum Separators, Blood Collection19
FMINeedle, Hypodermic, Single Lumen11
GIMTubes, Vacuum Sample, With Anticoagulant6

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 19, 2024K233979VACUETTE® QUICKSHIELD Complete (Plus)
Greiner Bio-One North America, Inc.
JKA
Jan 10, 2013K122687BLOOD CULTURE HOLDER
Greiner Bio-One North America, Inc.
JKA
Jul 25, 2012K121908SAFETY INFUSION SET
Greiner Bio-One North America, Inc.
FMI
Feb 17, 2012K113505VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
Greiner Bio-One North America, Inc.
FMI
Nov 9, 2010K103041VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
Greiner Bio-One North America, Inc.
JKA
Oct 15, 2010K102774VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
Greiner Bio-One North America, Inc.
FMI
Dec 16, 2008K081929VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
Greiner Bio-One North America, Inc.
JKA
Sep 14, 2007K072320GREINER VACUETTE QUICKSHIELD COMPLETE
Greiner Bio-One North America, Inc.
FMI
Jul 10, 2007K063357MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
Greiner Bio-One North America, Inc.
JKA
Aug 14, 2006K061483VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
Greiner Bio-One North America, Inc.
FMI

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 21, 2026Greiner 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
JKAK960857
Nov 19, 2025Greiner 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
JKAK081929
K983952
Oct 28, 2025Greiner Bio-One North America, Inc.
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Open, Classified
GIMK971221
Jul 17, 2024Greiner Bio-One North America, Inc.
VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Open, Classified
JKAK081929
K960858 +1
Jan 16, 2024Greiner 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
JKAK971239
May 12, 2023Greiner 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
JKAK960860
Dec 9, 2021Greiner 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
JKAK960857
Aug 20, 2021Greiner 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
GIMK971221
Aug 13, 2021Greiner Bio-One North America, Inc.
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Terminated
JKAK971236
May 6, 2021Greiner 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
GIMK971221
Aug 28, 2020Greiner 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
JKAK081929
Mar 12, 2020Greiner Bio-One North America, Inc.
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Terminated
GIMK971221
Nov 25, 2019Greiner 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
JKAK983952
Apr 26, 2016Greiner 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
JKAK971239
Feb 15, 2013Greiner 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
FMIK011786
Aug 7, 2012Greiner 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
GIMK971221
Jul 3, 2012Greiner 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
FMIK072320
Feb 22, 2012Greiner 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
JKAK960857
Nov 14, 2011Greiner Bio-One North America, Inc.
Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
Terminated
JKAK971236
Nov 9, 2011Greiner 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
FMIK102774
Aug 8, 2011Greiner 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
FMIK980768
Dec 16, 2010Greiner 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
JKAK960857
Nov 7, 2008Greiner 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
JKAK960857
Sep 30, 2008Greiner 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
FMIK980768
Sep 11, 2008Greiner 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
FMIK980768
Sep 13, 2006Greiner 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
GIMK971221
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