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Lower risk Medical device recall · FDA · Published May 14, 2024

Greiner Bio-One VACUETTE Tube Recall: Clotting Issues May Delay Treatment

Greiner Bio-One recalls 8ml blood collection tubes with clotting problems that may require retesting, risking treatment delays. Affected tubes have red cap with yellow ring and non-ridged design.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2375-2024Medical deviceGreiner Bio-One ›
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Contact the company

Recalling firmGreiner Bio-One North America, Inc.4238 Capital Dr · Monroe, NC 28110-7681
✎ GovInfoNow plain-language explainer

Greiner Bio-One is recalling 8ml blood collection tubes that may clot improperly, requiring retesting and potentially delaying medical treatment. This affects patients needing blood tests where timely results are critical. Read more at govinfonow.com/recall/55117-greiner-bio-one-vacuette-tube-recall-clotting-issues-may-delay.

Source Summary by GovInfoNow · govinfonow.com/recall/55117-greiner-bio-one-vacuette-tube-recall-clotting-issues-may-delay · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2375-2024

Cite this page

“Greiner Bio-One VACUETTE Tube Recall: Clotting Issues May Delay Treatment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55117-greiner-bio-one-vacuette-tube-recall-clotting-issues-may-delay. Based on FDA recall #Z-2375-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2375-2024%22&limit=1).

The FDA announced on 2024-05-14 that Greiner Bio-One North America, Inc. is recalling VACUETTE blood collection tubes due to missing additive causing clotting issues. The agency stated the failure may require sample recollection and delay treatment.

How to tell if you have it

  • Brand: Greiner Bio-One
  • Product: VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
  • Item Number: 455071P
  • UDI Case label: 39120017573068
  • UDI Rack label: 29120017573061
  • Lot Number: B24013MV

The hazard

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.

Context

GovInfoNow's records show Greiner Bio-One North America, Inc. has 11 other recalls on record since 2019-11-25. Other recent recalls of similar products include Vacuette 8ml CAT Serum Separator Clot Activator Tubes May Cause Incorrect Test Results (2025-08-19), Greiner Bio-One VACUETTE 2ml Coagulation Tubes: Incorrect Fill Level Label May Cause Repeat Collections (2025-08-08), and Greiner Bio-One VACUETTE Tube 4ml FX: Clotting Risk in Blood Tests (2023-12-12). Other recent recalls of similar products include Fresenius Medical Care 5008X Blood Tubing Set Recall: Risk of Blood Leak During Treatment (2026-08-10), Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall: Blood Leak Risk (2026-08-10), and Merit Medical BioFlo DuraMax Catheter Recall: Design Defect May Cause Bleeding (2026-02-13).

How to tell if you have this one

Check for tubes with a red cap and yellow ring, non-ridged design, and the model number 455071P. The lot number B24013MV is also associated with this recall.

  • Brand
    Greiner Bio-One
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Tube Condition

    Inspect the tube for proper clotting additive; if missing, it may need retesting.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 42 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: May 14, 202412. FDA classified it Class II: Jul 17, 202423. Published in FDA’s Enforcement Report: Jul 24, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2375-2024 (May 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2375-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA