Lower riskMedical device recall · FDA · Published November 25, 2019
Greiner Bio-One VACUETTE Tubes Recall: Vacuum Loss Risk
Greiner Bio-One recalls 3.5mL Serup Sep Clot Activator tubes with potential vacuum loss. Affected units may not fill properly during blood collection. Contact for remedy details.
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.
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 3.5mL Serup Sep Cl: Clot Activator tubes that may have damaged sealing at the cap. This could cause vacuum loss and improper blood collection volume. Affected tubes might not fill correctly when used for blood draws. Read more at govinfonow.com/recall/66430-greiner-bio-one-vacuette-tubes-recall-vacuum-loss-risk.
“Greiner Bio-One VACUETTE Tubes Recall: Vacuum Loss Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66430-greiner-bio-one-vacuette-tubes-recall-vacuum-loss-risk. Based on FDA recall #Z-0818-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0818-2020%22&limit=1).
The FDA announced on November 25, 2019, that Greiner Bio-One North America, Inc. is recalling VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P due to potential vacuum loss from cap sealing damage. The agency said the recall involves 1,002,000 tubes distributed in Illinois, Missouri, Arizona, North Carolina, Pennsylvania, Utah, New York, Maine, Puerto Rico, and Virginia.
How to tell if you have it
Brand: Greiner Bio-One
Product: VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator
Reference Number: REF 454067P
Lot Code: B190338E
Date of Issue (DI): 29120049204476
The hazard
According to the FDA, the Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This defect can lead to vacuum loss and prevent the tubes from filling to the proper volume.
Context
GovInfoNow's records show Greiner Bio-One North America, Inc. has had 11 other recalls since March 12, 2020. Recent similar recalls include a Vacuette 8ml CAT Serum Separator Clot Activator Tubes recall on August 19, 2025, and a Greiner Bio-One VACUETTE 2ml Coagulation Tubes recall on August 8, 2025. Other recent recalls of similar products include a Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall on August 10, 2026, and a Medline Blood Culture Kit Recall on December 24, 2025.
How to tell if you have this one
Check for the model number 454067P on the tube. The product was sold with lot number B190338E and serial number 29120049204476.
Brand
Greiner Bio-One
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Tube Condition
Inspect the cap sealing area for damage or cracks that could cause vacuum loss.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Illinois, Maine, Missouri, New York, North Carolina, Pennsylvania, Puerto Rico, Utah, Virginia.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0818-2020 (November 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0818-2020 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.