Data / Medical devices / United States / Greiner Bio-One North America, Inc.
Greiner Bio-One North America, Inc.: FDA-registered device maker in Monroe, NC, United States, 13 510(k) clearances
Greiner Bio-One North America, Inc. is registered with the FDA (registration 1125230) in Monroe, NC, United States. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated April 15, 2005. 30 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1125230
- FEI number
- 3001451379
- Address
- 4238 Capital Dr, Monroe, NC, United States, 28110
- Owner or operator
- GREINER BIO-ONE NA (8020040)
- Roles
- Manufacturer
- First device listed
- June 23, 1997
- Registered through
- 2026
- Brand names listed
- Blood Transfer Unit, MiniCollect Carrier Tubes, MiniCollect Funnel, VACUETTE Blood Collection Tube K2EDTA, VACUETTE Blood Collection Tube K3EDTA, VACUETTE Blood Collection Tube Lithium Heparin, VACUETTE Blood Collection Tube Lithium Heparin Sep, VACUETTE Blood Collection Tube Serum Clot Activator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood/Plasma Collection Device For Dna Testing | PJE | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vacuum Sample, With Anticoagulant | GIM | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2005 | K042927 | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | PJE | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| December 29, 2003 | K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | FMI | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| January 27, 2003 | K023971 | VACUETTE TRACE ELEMENTS TUBES | JKA | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| February 1, 2002 | K014104 | VACUETTE EDTA K2 TUBES | PJE | Substantially Equivalent | Greiner Vacuette North America, Inc. | accessdata.fda.gov |
| September 24, 2001 | K012043 | VACUETTE EDTA K2 GEL TUBES | PJE | Substantially Equivalent | Greiner Vacuette North America, Inc. | accessdata.fda.gov |
| June 28, 2001 | K011699 | VACUETTE EVACUATED BLOOD COLLECTION TUBES | JKA | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
| December 28, 1998 | K983952 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | Substantially Equivalent | Greiner Meditech, Inc. | accessdata.fda.gov |
| February 5, 1998 | K974873 | VACUETTE (MULTI-USE HOLDER) | JKA | Substantially Equivalent | Greiner Meditech, Inc. | accessdata.fda.gov |
| May 12, 1997 | K971236 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| May 2, 1997 | K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE | GIM | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| September 5, 1996 | K960860 | GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| August 30, 1996 | K960858 | GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
| August 30, 1996 | K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 29, 2026 | 99518 | Class II | Ongoing | 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 75 mm, 3.5ml) | Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia. | accessdata.fda.gov |
| August 19, 2025 | 97499 | Class II | Ongoing | 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 Stop | Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect r | accessdata.fda.gov |
| August 8, 2025 | 97457 | Class II | Ongoing | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 | Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections. | accessdata.fda.gov |
| May 14, 2024 | 94817 | Class II | Ongoing | VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged | The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment. | accessdata.fda.gov |
| December 12, 2023 | 93606 | Class II | Ongoing | VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged. | Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment. | accessdata.fda.gov |
| March 31, 2023 | 92025 | Class II | Completed | 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 | Some of the tubes may be incorrectly labeled. | accessdata.fda.gov |
| December 9, 2021 | 89216 | Class II | Terminated | 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 | Some of the blood collection tubes show clotting due to variation of Lithium Heparin. | accessdata.fda.gov |
| August 20, 2021 | 88563 | Class II | Terminated | Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged | Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. | accessdata.fda.gov |
| August 13, 2021 | 88511 | Class II | Terminated | VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged | Blood collection tubes may experience a clotting issue. | accessdata.fda.gov |
| March 29, 2021 | 87660 | Class II | Terminated | 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 | VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays. | accessdata.fda.gov |
| August 28, 2020 | 86363 | Class II | Terminated | 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. | Blood collection tubes experienced an issue with separation and clotting | accessdata.fda.gov |
| March 12, 2020 | 85215 | Class II | Terminated | VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355. | Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate. | accessdata.fda.gov |
| November 25, 2019 | 84536 | Class II | Terminated | 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 used to collect, tr | The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume. | accessdata.fda.gov |
| April 26, 2016 | 74002 | Class II | Terminated | 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 suitable for the an | The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate. | accessdata.fda.gov |
| February 1, 2013 | 64321 | Class II | Terminated | 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. | The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece. | accessdata.fda.gov |
| July 2, 2012 | 62595 | Class II | Terminated | 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. | Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. | accessdata.fda.gov |
| April 2, 2012 | 62447 | Class II | Terminated | 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 venipuncture procedures. | : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable. | accessdata.fda.gov |
| December 14, 2011 | 60748 | Not yet classified | Terminated | LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes. | The lithium heparin tubes may have a contamination with EDTA potassium. | accessdata.fda.gov |
| August 12, 2011 | 59919 | Not yet classified | Terminated | Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209. | Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills. | accessdata.fda.gov |
| August 11, 2011 | 59918 | Not yet classified | Terminated | 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 Collection Tubes as a sy | Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub. | accessdata.fda.gov |
| June 29, 2011 | 59352 | Not yet classified | Terminated | 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 steel needle on the undersi | At removal of the tube from the holder, the needle may dislodge and blood spill can occur. | accessdata.fda.gov |
| August 25, 2010 | 56679 | Not yet classified | Terminated | Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes. | Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results. | accessdata.fda.gov |
| August 5, 2008 | 49367 | Not yet classified | Terminated | 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. | At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out. | accessdata.fda.gov |
| July 29, 2008 | 49371 | Not yet classified | Terminated | 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 bio-one NA, Inc., 4238 Ca | Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and rack label information showed the correct information with 2 ml Lithium Heparin. | accessdata.fda.gov |
| May 16, 2008 | 48455 | Not yet classified | Terminated | 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 holder. It is intend | At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out. | accessdata.fda.gov |
| August 2, 2006 | 36027 | Not yet classified | Terminated | 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 * Sterile * manufactured | Coagulation tubes found with no additive. | accessdata.fda.gov |
| July 28, 2005 | 32826 | Not yet classified | Terminated | Serum Blood Collection Tubes | Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution. | accessdata.fda.gov |
| July 27, 2004 | 29652 | Not yet classified | Terminated | Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile. | Coagulation tubes may not have received the proper fill of citrate solution. | accessdata.fda.gov |
| December 16, 2003 | 28126 | Not yet classified | Terminated | Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria. | Product may have a defective connection. | accessdata.fda.gov |
| March 10, 2003 | 25738 | Not yet classified | Terminated | Vacuette, Safety Blood Collection Set with Luer Adapter | The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Container, Specimen, Sterile
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Tubes, Vacuum Sample, With Anticoagulant
- All makers of Blood/Plasma Collection Device For Dna Testing
Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.