The Recall Desk

Manufacturer

Greiner Bio-One North America, Inc.

16 recalls in our database name Greiner Bio-One North America, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
0
Most recent
2025-11-26

Of the 16 recalls from Greiner Bio-One North America, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • HighFDA (Devices)·Z-0571-2026·2025-11-26

    Blood tubes recalled after being manufactured without the gel separator

    Greiner Bio-One is recalling 1,980,000 Vacuette 8 ml serum separator tubes because some were manufactured without the gel separator, which could yield erroneous assay results.

    Product
    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)
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-0408-2026·2025-11-05

    Coagulation blood tubes recalled over a misplaced label shifting the fill mark

    Greiner Bio-One is recalling 504,000 VACUETTE 2 ml coagulation tubes because the label was applied too high, shifting the printed fill level mark upward.

    Product
    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2375-2024·2024-07-24

    Blood collection tubes recalled for missing additive and separation failures

    Greiner Bio-One is recalling VACUETTE blood collection tubes due to missing additive affecting clotting and separation. Defective tubes could delay patient treatment if samples require recollection.

    Product
    VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2024·2024-01-24

    VACUETTE Blood Collection Tubes Missing Critical Anticoagulant Additive

    VACUETTE blood collection tubes are missing an anticoagulant additive, causing samples to clot and producing inaccurate or absent lab results. This can delay diagnosis or lead to inappropriate treatment.

    Product
    VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1583-2023·2023-05-24

    Greiner Bio-One Blood Collection Tubes Recalled for Labeling Error

    Greiner Bio-One blood collection tubes (VACUETTE TUBE 6ml K3EDTA) may be incorrectly labeled. The company is recalling 36,000 units distributed in Wisconsin and Georgia.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2022·2022-01-26

    Blood Collection Tubes Recalled Due to Lithium Heparin Variation

    Greiner Bio-One is recalling 889,200 blood collection tubes (Lot #B21053QG) due to variation in lithium heparin that may cause blood clotting. The tubes were distributed to ten U.S. states.

    Product
    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
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2485-2021·2021-10-06

    Blood collection tubes recalled due to potential clotting defect

    Greiner Bio-One North America is recalling VACUETTE blood collection tubes (6 ml K2E) because they may experience a clotting issue. Approximately 962,400 tubes were distributed across 15 US states and Canada.

    Product
    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2507-2021·2021-09-29

    Greiner VACUETTE 2 ml Coagulation Blood Collection Tubes Anticoagulant and Vacuum Recall

    Greiner Bio-One is recalling 956,400 VACUETTE coagulation blood collection tubes that may clot due to anticoagulant variation or low vacuum.

    Product
    Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2021·2021-05-12

    Greiner Bio-One Recalls VACUETTE Blood Collection Tubes for Insufficient Draw Volume

    Greiner Bio-One is recalling VACUETTE blood collection tubes because insufficient draw volume may cause erroneous coagulation test results.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3027-2020·2020-10-07

    Greiner Bio-One Recalls VACUETTE Blood Collection Tubes Due to Separation Issues

    Greiner Bio-One is recalling VACUETTE blood collection tubes because they experienced an issue with separation and clotting.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1714-2020·2020-04-22

    Greiner Bio-One Recalls VACUETTE Coagulation Tubes Due to Anticoagulant Inconsistency

    Greiner Bio-One is recalling VACUETTE 2mL 9NC Coagulation Tubes because the sodium citrate anticoagulant levels were inconsistent. The recall affects 1,000,800 units distributed nationwide.

    Product
    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0818-2020·2020-01-29

    Greiner Bio-One Recalls Damaged Vacuette Blood Collection Tubes

    Greiner Bio-One is recalling 1,002,000 Vacuette tubes that may have cap sealing damage, potentially causing vacuum loss and improper blood volume collection.

    Product
    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 who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1923-2016·2016-06-15

    Greiner Bio-One Recalls 4 ml FX Sodium Fluoride Tubes

    Greiner Bio-One is recalling 4 ml FX Sodium Fluoride/Potassium Oxalate tubes because they may contain low or no additives, potentially affecting glucose and lactate test results.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2013·2013-02-27

    Greiner Bio-One Recalls VACUETTE Safety Blood Collection Sets

    Greiner Bio-One is recalling VACUETTE Safety Blood Collection Sets because a crack in the luer connector may cause small droplets of blood to leak during use.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2154-2012·2012-08-15

    Greiner Bio-One Recalls Coagulation Blood Collection Tubes Due to Concentration Error

    Greiner Bio-One is recalling specific lots of 3mL coagulation blood collection tubes because a lower citrate concentration may cause falsely low test results.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2012·2012-07-11

    Greiner Bio-One Recalls Vacuette Quickshield Complete Plus Blood Collection Devices

    Greiner Bio-One is recalling specific lots of Vacuette Quickshield Complete Plus devices due to a defect that may cause the safety shield to become loose and unstable.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Greiner Bio-One

Austrian life science company

Country
Austria
Founded
2001

Official website

Source: Wikidata (Q1545532), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.