RegWardenFDA facility compliance records
Facility

GREINER BIO-ONE NORTH AMERICA, INC.

16 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 2 recalls; 2013: 1 recalls; 2016: 1 recalls; 2017: 1 inspections; 2019: 1 recalls, 1 inspections; 2020: 2 recalls, 1 warning letters; 2021: 4 recalls, 1 inspections; 2023: 2 recalls, 1 inspections; 2024: 1 recalls; 2025: 2 recalls2’121’13’14’151’161’17’182’193’205’21’223’231’242’25’26
  • Recalls (16)
  • Inspections (4)
  • Warning letters (1)

Devices registered here (1)

  • Blood/Plasma Collection Device For Dna Testing
    Product code PJE (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1675

Recalls & enforcement

20252 records
  • Class IIOngoing2025-08-19
    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 …
  • Class IIOngoing2025-08-08
    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.
20241 record
  • Class IIOngoing2024-05-14
    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.
20232 records
  • Class IIOngoing2023-12-12
    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 …
  • Class IICompleted2023-03-31
    Some of the tubes may be incorrectly labeled.
20214 records
  • Class IITerminated2021-12-09
    Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
  • Class IITerminated2021-08-20
    Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
  • Class IITerminated2021-08-13
    Blood collection tubes may experience a clotting issue.
  • Class IITerminated2021-03-29
    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.
20202 records
20191 record
  • Class IITerminated2019-11-25
    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.
20161 record
  • Class IITerminated2016-04-26
    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.
20131 record
  • Class IITerminated2013-02-01
    The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
20122 records
  • Class IITerminated2012-07-02
    Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
  • Class IITerminated2012-04-02
    : 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.

FDA inspections (4)

  • NAI2023-09-14
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • VAI2021-10-29
    Voluntary Action Indicated · Compliance: Devices · citations posted
  • OAI2019-12-13
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2017-08-17
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “GREINER BIO-ONE NORTH AMERICA, INC. (FEI 3001451379) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001451379-greiner-bio-one-north-america-inc/

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