Lower risk Medical device recall · FDA · Published August 19, 2025

Vacuette 8ml CAT Serum Separator Clot Activator Tubes May Cause Incorrect Test Results

Greiner Bio-One recalls 8ml Vacuette CAT serum separator tubes (model 455071P) that may cause incorrect lab results due to missing gel separator, potentially delaying diagnosis and treatment.

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

🇺🇸 FDA recall #Z-0571-2026Medical device Vacuette ›

Lower-risk recall

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 in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

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 recalls Vacuette 8ml CAT serum separator tubes that may have missing gel separators. This could lead to incorrect lab results, requiring repeat testing and possibly delaying diagnosis or treatment. Read more at govinfonow.com/recall/51595-vacuette-8ml-cat-serum-separator-clot-activator-tubes-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/51595-vacuette-8ml-cat-serum-separator-clot-activator-tubes-may-cause · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0571-2026

Cite this page

“Vacuette 8ml CAT Serum Separator Clot Activator Tubes May Cause Incorrect Test Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51595-vacuette-8ml-cat-serum-separator-clot-activator-tubes-may-cause. Based on FDA recall #Z-0571-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0571-2026%22&limit=1).

The FDA announced on August 19, 2025, that Greiner Bio-One North America, Inc. is recalling Vacuette 8 ml CAT Serum Separator Clot Activator tubes because some were manufactured without a gel separator. This defect could yield erroneous assay results and require patients to return for repeat testing.

How to tell if you have it

Brand: Vacuette
Product Name: 8 ml CAT Serum Separator Clot Activator
Model/Catalog Number: 455071P
Lot Code: B250437N
UDI-DI code: 29120017573061

The hazard

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 in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

Context

GovInfoNow's records show Greiner Bio-One North America, Inc. has 11 other recalls on record since November 25, 2019. Other recent recalls of similar products include Copan Italia DTT Liquid Reagent Recall (October 29, 2025), Stryker Daig Livewire Steerable Catheter Recall (April 10, 2026) and Medline Medical Procedure Kits Recall (May 4, 2026).

How to tell if you have this one

Check for the model number 455071P on the tube. The lot number B250437N is associated with this specific batch.

Brand
Vacuette
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Tube Details
Look for the model number 455071P and lot number B250437N on the tube.

Where it went and when

Where it was distributed

Distributed in 28 states.

FDA distribution: “U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY. O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wyoming.

Recall timeline

FDA published this recall 3 months after the firm started it.

Aug 19, 2025Firm started the recall
Nov 19, 2025FDA classified it Class II
Nov 26, 2025Published in FDA’s Enforcement Report

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/51595-vacuette-8ml-cat-serum-separator-clot-activator-tubes-may-cause">Vacuette 8ml CAT Serum Separator Clot Activator Tubes May Cause Incorrect 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-0571-2026 (August 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0571-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.