Greiner Bio-One North America, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3001451379
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 254 ongoing
What Greiner Bio-One North America, Inc. makes
Greiner Bio-One North America, Inc. manufactures blood collection and infusion devices, including VACUETTE blood collection tubes with clot activator, gel separator, lithium heparin, and other additives, as well as VACUETTE QuickShield holders and safety blood collection needles such as VACUETTE VISIO PLUS. The company also produces capillary blood collection tubes under the MiniCollect line, blood culture holders, and safety infusion sets.
All listed devices are classified as Class II medical devices and are registered in the FDA 510(k) database. The company is based in the United States.
Catalogue
Vacuette Quickshield With Snappy Tude Holder Ref K102774
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Vacuette Quickshield With Snappy Tube Holder Ref K113505
Regimes: 510(k) Registry: 510(k)VACUETTE® QUICKSHIELD Complete (Plus) Ref K233979
Regimes: 510(k) Registry: 510(k)Vacuette Visio Plus Blood Collection Needles Ref K061483
Regimes: 510(k) Registry: 510(k)Safety Infusion Set Ref K121908
Regimes: 510(k) Registry: 510(k)Greiner Vacuette Quickshield Complete Ref K072320
Regimes: 510(k) Registry: 510(k)Blood Culture Holder Ref K122687
Regimes: 510(k) Registry: 510(k)Minicollect Capillary Blood Collection Tubes Ref K063357
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3001451379
- Address
- 4238 Capital Dr, MONROE, NC, 28110
FDA recalls
FDA recall records list 25 recalls initiated by GREINER BIO-ONE NORTH AMERICA, INC., the earliest on 2006-08-02 and the most recent on 2025-08-19. By recorded status: 4 ongoing, 20 terminated and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 2
- 2021 4
- 2022 0
- 2023 2
- 2024 1
- 2025 2
- 2026 0
2025
- 19 Aug 2025 Z-0571-2026 Class II Ongoing 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.
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- 8 Aug 2025 Z-0408-2026 Class II Ongoing 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.
- 19 Aug 2025 Z-0571-2026 Class II Ongoing 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.
2024
- 14 May 2024 Z-2375-2024 Class II Ongoing 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.
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- 14 May 2024 Z-2375-2024 Class II Ongoing 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.
2023
- 12 Dec 2023 Z-0733-2024 Class II Ongoing 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.
- 31 Mar 2023 Z-1583-2023 Class II Completed Some of the tubes may be incorrectly labeled.
2021
- 9 Dec 2021 Z-0502-2022 Class II Terminated Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
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- 20 Aug 2021 Z-2507-2021 Class II Terminated Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
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- 13 Aug 2021 Z-2485-2021 Class II Terminated Blood collection tubes may experience a clotting issue.
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- 29 Mar 2021 Z-1534-2021 Class II Terminated 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.
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- 9 Dec 2021 Z-0502-2022 Class II Terminated Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
2020
- 28 Aug 2020 Z-3027-2020 Class II Terminated Blood collection tubes experienced an issue with separation and clotting
Show all 25 recalls
2020
- 12 Mar 2020 Z-1714-2020 Class II Terminated Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
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- 12 Mar 2020 Z-1714-2020 Class II Terminated Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
2019
- 25 Nov 2019 Z-0818-2020 Class II Terminated 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.
2016
- 26 Apr 2016 Z-1923-2016 Class II Terminated 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.
2013
- 1 Feb 2013 Z-0835-2013 Class II Terminated The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
2012
- 2 Jul 2012 Z-2154-2012 Class II Terminated Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
- 2 Apr 2012 Z-1935-2012 Class II Terminated : 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.
2011
- 14 Dec 2011 Z-1081-2012 Unclassified (pre-2012) Terminated The lithium heparin tubes may have a contamination with EDTA potassium.
- 12 Aug 2011 Z-0184-2012 Unclassified (pre-2012) Terminated Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.
- 11 Aug 2011 Z-0179-2012 Unclassified (pre-2012) Terminated Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
- 29 Jun 2011 Z-2957-2011 Unclassified (pre-2012) Terminated At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
2010
- 25 Aug 2010 Z-0623-2011 Unclassified (pre-2012) Terminated 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.
2008
- 5 Aug 2008 Z-2198-2008 Unclassified (pre-2012) Terminated 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.
- 29 Jul 2008 Z-0215-2009 Unclassified (pre-2012) Terminated 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.
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- 16 May 2008 Z-2134-2008 Unclassified (pre-2012) Terminated 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.
2006
- 2 Aug 2006 Z-1498-06 Unclassified (pre-2012) Terminated Coagulation tubes found with no additive.
Frequently asked questions
How many devices does GREINER BIO-ONE NORTH AMERICA, INC. have in the registry?
The registry currently lists 10 devices for GREINER BIO-ONE NORTH AMERICA, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GREINER BIO-ONE NORTH AMERICA, INC.'s devices?
Among its 10 most recently registered devices, GREINER BIO-ONE NORTH AMERICA, INC. has devices listed in FDA 510(k) (10 devices).
What risk classes do GREINER BIO-ONE NORTH AMERICA, INC.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for GREINER BIO-ONE NORTH AMERICA, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for GREINER BIO-ONE NORTH AMERICA, INC.?
FDA recall records list 25 recalls initiated by GREINER BIO-ONE NORTH AMERICA, INC., the most recent initiated on 19 Aug 2025. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from GREINER BIO-ONE NORTH AMERICA, INC. in the registry?
The most recently registered devices listed for GREINER BIO-ONE NORTH AMERICA, INC. include VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER, VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR, VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER and VACUETTE® QUICKSHIELD Complete (Plus).