Greiner Bio-One recalls 5mL CAT serum separator blood collection tubes with clotting problems. Affected lots may cause inaccurate blood test results. Contact for replacement.
“Greiner Bio-One VACUETTE 5mL Blood Tubes Recall: Clotting Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64420-greiner-bio-one-vacuette-5ml-blood-tubes-recall-clotting-issues. Based on FDA recall #Z-3027-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3027-2020%22&limit=1).
The FDA announced on Aug. 28, 2020, that Greiner Bio-One North America, Inc. voluntarily recalled VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator tubes due to separation and clotting issues. The agency classified the recall as Class II.
How to tell if you have it
Brand: Greiner Bio-One
Product: VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator
Item Number: 456018P
Lot Number: B2003399
Quantity: 1,008,000 pieces
The hazard
According to the FDA, the blood collection tubes experienced an issue with separation and clotting. These defects could affect the ability to collect, transport, and process blood for testing serum, plasma, or whole blood in clinical laboratories.
Context
GovInfoNow's records show Greiner Bio-One North America, Inc. has had 11 other recalls since Nov. 25, 2019. Other recent recalls of similar products include Vacuette 8ml CAT Serum Separator Clot Activator Tubes (Aug. 19, 2025), Greiner Bio-One VACUETTE 2ml Coagulation Tubes (Aug. 8, 2025), and Greiner Bio-One VACUETTE Tube Recall (May 14, 2024). Other recent recalls of similar products include Merit Medical BioFlo DuraMax Catheter Recall (Feb. 13, 2026), Copan Italia DTT Liquid Reagent Recall (Oct. 29, 2025), and Fresenius Medical Care 5008X Blood Tubing Set Recall (Aug. 10, 2026).
How to tell if you have this one
Check for the item number 456018P on the tube. The lot number B2003399 is associated with this recall. These tubes are used for blood collection in clinical laboratories.
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 B2003399 on the tube's label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of IL, PA, VA, MO, NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Missouri, New York, Pennsylvania, 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-3027-2020 (August 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3027-2020 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.