Monroe, NC, United States
Greiner Bio-One North America, Inc. recalls
12 recalls recorded since 2018, most recently on 19 August 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)4
Terminated or completed8
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 August 2025
- Reason
- 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.
- Distribution
- U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 S
Ongoing Class II Medical devices
- Recall started
- 8 August 2025
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0408-2026
- Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Ongoing Class II Medical devices
- Recall started
- 14 May 2024
- Reason
- 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.
- Distribution
- Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV and WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2375-2024
- VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Ongoing Class II Medical devices
- Recall started
- 12 December 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0733-2024
- VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Completed Class II Medical devices
- Recall started
- 31 March 2023
- Reason
- Some of the tubes may be incorrectly labeled.
- Distribution
- US Nationwide distribution in the states of WI and GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 9 December 2021
- Terminated
- 10 October 2023
- Reason
- Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
- Distribution
- Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 20 August 2021
- Terminated
- 4 October 2023
- Reason
- Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 13 August 2021
- Terminated
- 16 August 2023
- Reason
- Blood collection tubes may experience a clotting issue.
- Distribution
- Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2485-2021
- VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Terminated Class II Medical devices
- Recall started
- 29 March 2021
- Terminated
- 10 October 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 coagulati
Terminated Class II Medical devices
- Recall started
- 28 August 2020
- Terminated
- 17 June 2021
- Reason
- Blood collection tubes experienced an issue with separation and clotting
- Distribution
- US Nationwide distribution including in the states of IL, PA, VA, MO, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class II Medical devices
- Recall started
- 12 March 2020
- Terminated
- 31 August 2022
- Reason
- Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
- Distribution
- US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1714-2020
- VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Terminated Class II Medical devices
- Recall started
- 25 November 2019
- Terminated
- 5 October 2020
- Reason
- 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.
- Distribution
- Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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, tr
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.