Lower risk Medical device recall · FDA · Published March 29, 2021

Greiner Bio-One VACUETTE Blood Collection Tubes May Cause Erroneous Test Results

Greiner Bio-One recalls VACUETTE blood collection tubes that may show insufficient draw volume, leading to inaccurate coagulation test results. Affected tubes have specific model numbers and expiration dates.

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

🇺🇸 FDA recall #Z-1534-2021Medical device Greiner Bio-One ›

Lower-risk recall

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.

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 VACUETTE blood collection tubes that may not draw enough blood, causing inaccurate coagulation test results. This could lead to incorrect medical diagnoses if used for blood tests. Read more at govinfonow.com/recall/62890-greiner-bio-one-vacuette-blood-collection-tubes-may-cause-erroneous.

Source Summary by GovInfoNow · govinfonow.com/recall/62890-greiner-bio-one-vacuette-blood-collection-tubes-may-cause-erroneous · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1534-2021

Cite this page

“Greiner Bio-One VACUETTE Blood Collection Tubes May Cause Erroneous Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62890-greiner-bio-one-vacuette-blood-collection-tubes-may-cause-erroneous. Based on FDA recall #Z-1534-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1534-2021%22&limit=1).

The FDA announced on March 29, 2021, that Greiner Bio-One North America, Inc. is recalling VACUETTE Blood Collection tubes due to insufficient draw volume that could produce erroneous coagulation test results. The agency has classified this Class II recall as terminated.

How to tell if you have it

Brand: Greiner Bio-One
Product: VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube
Item Number: 454322; Lot # A21023B5; UDI: (Case) 39120017574485 and (Rack) 29120017574488; Expiration Date: 02/06/2022
Item Number: 454332; Lot # A210338Q; UDI: (Case) 39120017574607 and (Rack) 29120017574600; Expiration Date: 03/01/2022
Item Number: 454334; Lot # A210233V; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/01/2022
Item Number: 454334; Lot # A21023XW; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/13/2022
Units affected: 1,049,700

The hazard

According to the FDA, the VACUETTE Blood Collection tubes may show insufficient draw volume, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.

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).

How to tell if you have this one

Check for the model number 9NC Coagulation sodium citrate 3.2% with a blue cap and white ring. The tubes have specific expiration dates: February 2022 through March 2022.

Brand
Greiner Bio-One
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Tube Expiration
Verify the expiration date on the tube label to ensure it matches the dates listed in the recall (February 2022 through March 2022).
Confirm Product Model
Look for the model number 9NC Coagulation sodium citrate 3.2% with a blue cap and white ring on the tube.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 18 states.

FDA distribution: “US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Florida, Illinois, Kansas, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Texas.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

Mar 29, 2021Firm started the recall
May 6, 2021FDA classified it Class II
May 12, 2021Published in FDA’s Enforcement Report
Oct 10, 2023FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any safety risks from using these tubes?

No, the tubes do not pose a physical safety risk like cuts or fires, but they can cause inaccurate test results if used improperly.

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Link to this recall

<a href="https://govinfonow.com/recall/62890-greiner-bio-one-vacuette-blood-collection-tubes-may-cause-erroneous">Greiner Bio-One VACUETTE Blood Collection Tubes May Cause Erroneous Test Results (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-1534-2021 (March 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1534-2021 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.