Greiner Bio-One recalls VACUETTE 4ml FX tubes with missing anticoagulant that may cause blood clots, leading to inaccurate test results and delayed treatment. Affected tubes have specific color and model numbers.
Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
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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 4ml FX blood collection tubes because they may clot due to missing anticoagulant. This could cause inaccurate test results, delayed diagnosis, or improper treatment if blood samples are used for glucose or lactose tests. Read more at govinfonow.com/recall/56568-greiner-bio-one-vacuette-tube-4ml-fx-clotting-risk-in.
“Greiner Bio-One VACUETTE Tube 4ml FX: Clotting Risk in Blood Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56568-greiner-bio-one-vacuette-tube-4ml-fx-clotting-risk-in. Based on FDA recall #Z-0733-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0733-2024%22&limit=1).
The FDA announced on Dec. 12, 2023, that Greiner Bio-One North America is recalling VACUETTE blood collection tubes due to missing additives that cause clotting. This defect can lead to delayed diagnosis or inappropriate treatment based on erroneous test results.
How to tell if you have it
Brand: Greiner Bio-One
Product: VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate
According to the FDA, the tubes have missing additive or anticoagulant resulting in clotting. A completely clotted sample leads to no results being reported, which could delay treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
Context
GovInfoNow's records show Greiner Bio-One North America has 11 other recalls on record 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 HemosIL SynthAFax Partial Thromboplastin Time Tests (Nov. 18, 2025), AVID Medical Halyard Kits (April 30, 2026), and Beckman Coulter DxH Diluent (Nov. 10, 2025).
How to tell if you have this one
Check for the 13x75 grey cap with black ring, non-ridged design. The tubes have lot number A221135N and expire March 2, 2024.
Brand
Greiner Bio-One
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Tube Details
Look for the 13x75 grey cap with black ring and non-ridged design on the tube.
Contact Manufacturer
Reach out to Greiner Bio-One for assistance with affected tubes or replacement options.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Florida, Illinois, Iowa, Missouri, New York, North Carolina, Pennsylvania, Tennessee, Virginia.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0733-2024 (December 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0733-2024 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.