Greiner Bio-One North America, Inc.
Monroe, NC, US
GREINER BIO-ONE NORTH AMERICA, INC. appears in FDA device records in Monroe, NC. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Greiner Bio-One North America, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Greiner Vacuette North America, Inc.510(k), recall
510(k) clearance history
FDA records hold 15 510(k) clearances for Greiner Bio-One North America, Inc. between 2000 and 2024. The busiest year on record is 2001, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2010 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | JKA | Substantially Equivalent | |
| K122687 | BLOOD CULTURE HOLDER | JKA | Substantially Equivalent | |
| K121908 | SAFETY INFUSION SET | FMI | Substantially Equivalent | |
| K113505 | VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER | FMI | Substantially Equivalent | |
| K103041 | VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR | JKA | Substantially Equivalent | |
| K102774 | VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER | FMI | Substantially Equivalent | |
| K081929 | VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR | JKA | Substantially Equivalent | |
| K072320 | GREINER VACUETTE QUICKSHIELD COMPLETE | FMI | Substantially Equivalent | |
| K063357 | MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES | JKA | Substantially Equivalent | |
| K061483 | VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES | FMI | Substantially Equivalent | |
| K014104 | VACUETTE EDTA K2 TUBES | PJE | Substantially Equivalent | |
| K012043 | VACUETTE EDTA K2 GEL TUBES | PJE | Substantially Equivalent | |
| K011786 | VACUETTE SAFETY BLOOD COLLECTION SET | FMI | Substantially Equivalent | |
| K003812 | VACUETTE SPEEDY QUICK-RELEASE HOLDER | FMI | Substantially Equivalent | |
| K002777 | VACUETTE WITH PPACK | JKA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1125230 | 3001451379 | GREINER BIO-ONE NORTH AMERICA, INC. | 4238 Capital Dr, MONROE, NC 28110 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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) | 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 results from less stable parameters. | Class II | Open, Classified | |
| Z-0408-2026 | 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. | Class II | Open, Classified | |
| Z-2375-2024 | 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. | Class II | Open, Classified | |
| Z-0733-2024 | 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. | Class II | Open, Classified | |
| 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 | Some of the tubes may be incorrectly labeled. | Class II | Completed | |
| 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 | Some of the blood collection tubes show clotting due to variation of Lithium Heparin. | Class II | Terminated | |
| 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 | Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. | Class II | Terminated | |
| Z-2485-2021 | VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged | Blood collection tubes may experience a clotting issue. | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| 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. | Blood collection tubes experienced an issue with separation and clotting | Class II | Terminated | |
| Z-1714-2020 | 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. | Class II | Terminated | |
| Z-0818-2020 | 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, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory. | 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. | Class II | Terminated | |
| Z-1923-2016 | 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 analysis of blood glucose and lactate | 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. | Class II | Terminated | |
| Z-0835-2013 | 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. | Class II | Terminated | |
| Z-2154-2012 | 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. | Class II | Terminated | |
| Z-1935-2012 | 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. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use. | : 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. | Class II | Terminated | |
| Z-1081-2012 | 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. | Terminated | ||
| Z-0184-2012 | 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. | Terminated | ||
| Z-0179-2012 | 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 system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions. | Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub. | Terminated | ||
| Z-2957-2011 | 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 underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures. | At removal of the tube from the holder, the needle may dislodge and blood spill can occur. | Terminated | ||
| Z-0623-2011 | 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. | Terminated | ||
| Z-2198-2008 | 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. | Terminated | ||
| Z-0215-2009 | 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 Capital Drive, Monroe, NC 28110. The Greiner Vacuette blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood. | 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. | Terminated | ||
| Z-2134-2008 | 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 intended for use in routine specimen withdrawal from collection bags or bottles through needless 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. | Terminated | ||
| Z-1498-06 | 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 by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA | Coagulation tubes found with no additive. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain