Greiner Bio-One recalls

8 official recalls and safety alerts involving Greiner Bio-One since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Greiner Bio-One or the relevant agency.

  1. 2025-11-26
  2. US
    Drugs & medicalClass II

    Greiner Bio-One North America, Inc. recalls Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product…

    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…

    FDA · DeviceGreiner Bio-One North America, Inc.U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS,…Official notice →
  3. 2025-11-05
  4. US
    Drugs & medicalClass II

    Greiner Bio-One North America, Inc. recalls 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.

    FDA · DeviceGreiner Bio-One North America, Inc.US Nationwide distribution.Official notice →
  5. 2025-01-15
  6. US
    Drugs & medicalClass II

    Greiner Bio-One GmbH recalls VACUETTE SAFELINK, REF: 450210

    The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

    FDA · DeviceGreiner Bio-One GmbHUS Nationwide distribution in the states of IL, PA.Official notice →
  7. 2024-07-24
  8. US
    Drugs & medicalClass II

    Greiner Bio-One North America, Inc. recalls 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…

    FDA · DeviceGreiner Bio-One North America, Inc.Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA,…Official notice →
  9. 2024-01-24
  10. US
    Drugs & medicalClass II

    Greiner Bio-One North America, Inc. recalls 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…

    FDA · DeviceGreiner Bio-One North America, Inc.US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA,…Official notice →
  11. 2023-05-24
  12. US
    Drugs & medicalClass II

    Greiner Bio-One North America, Inc. recalls greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in…

    Some of the tubes may be incorrectly labeled.

    FDA · DeviceGreiner Bio-One North America, Inc.US Nationwide distribution in the states of WI and GA.Official notice →
  13. 2022-01-26
  14. US
    Drugs & medicalClass II

    Greiner Bio-One North America, Inc. recalls greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs.,…

    Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

    FDA · DeviceGreiner Bio-One North America, Inc.Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was…Official notice →
  15. 2021-10-06
  16. US
    Drugs & medicalClass II

    Greiner Bio-One North America, Inc. recalls VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

    Blood collection tubes may experience a clotting issue.

    FDA · DeviceGreiner Bio-One North America, Inc.Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA,…Official notice →