Lower risk Medical device recall · FDA · Published August 20, 2021

Greiner Bio-One VACUETTE Tube Recall: Clotting Risk in 2ml Coagulation Tubes

Greiner Bio-One recalls 2ml coagulation tubes with sodium citrate 3.2% that may clot due to anticoagulant variation or low vacuum. Affected lots expired by 05/10/22 and 04/13/2022.

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

🇺🇸 FDA recall #Z-2507-2021Medical device Greiner Bio-One ›

Lower-risk recall

Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

Take action

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 2ml coagulation tubes that may clot because of anticoagulant issues or low vacuum. This could lead to inaccurate blood test results if used for coagulation tests. Read more at govinfonow.com/recall/61920-greiner-bio-one-vacuette-tube-recall-clotting-risk-in-2ml.

Source Summary by GovInfoNow · govinfonow.com/recall/61920-greiner-bio-one-vacuette-tube-recall-clotting-risk-in-2ml · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2507-2021

Cite this page

“Greiner Bio-One VACUETTE Tube Recall: Clotting Risk in 2ml Coagulation Tubes.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61920-greiner-bio-one-vacuette-tube-recall-clotting-risk-in-2ml. Based on FDA recall #Z-2507-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2507-2021%22&limit=1).

The FDA announced on 2021-08-20 that Greiner Bio-One North America, Inc. is recalling VACUETTE blood collection tubes due to clotting hazards from anticoagulant variations or low vacuum. The recall affects lots B210533B and B210439J distributed nationwide.

How to tell if you have it

Brand: Greiner Bio-One
Product: Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube
Lot codes: B210533B (Expiration 05/10/22), B210439J (Expiration 04/13/2022)
Units affected: 956,400

The hazard

The hazard involves complaints of tubes clotting due to variation of anticoagulant and/or tubes having low vacuum. The record does not report specific incidents or injuries.

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 Recall: Clotting Issues May Delay Treatment (2024-05-14). Other recent recalls of similar products include HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (2025-11-18), Instrumentation Laboratory Coagulation Test Kits Risk Microbial Contamination (2025-12-11), and AVID Medical Halyard Kits Recall: Particulates Risk Blood Clots (2026-04-30).

How to tell if you have this one

Check for the blue cap with a white ring on the tube. Look for lot numbers B210533B (expired 05/10/2022) or B210439J (expired 04/13/2022).

Brand
Greiner Bio-One
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Tube Lot Number
Look for the lot number on the tube to confirm if it's affected (B210533B or B210439J).

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 25 states.

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

Named in the notice: Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Missouri, Montana, Nebraska, Nevada, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Aug 20, 2021Firm started the recall
Sep 22, 2021FDA classified it Class II
Sep 29, 2021Published in FDA’s Enforcement Report
Oct 4, 2023FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/61920-greiner-bio-one-vacuette-tube-recall-clotting-risk-in-2ml">Greiner Bio-One VACUETTE Tube Recall: Clotting Risk in 2ml Coagulation Tubes (GovInfoNow)</a>

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-2507-2021 (August 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2507-2021 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.