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Lower risk Medical device recall · FDA · Published August 13, 2021

Greiner Bio-One VACUETTE 6ml Blood Tubes Risk of Clotting

Greiner Bio-One recalls 6ml K2EDTA blood collection tubes with pink caps that may clot during use. Affected lots expire 09/2022 or 11/2022. Stop using immediately to avoid inaccurate blood tests.

🇺🇸 FDA recall #Z-2485-2021Medical deviceGreiner Bio-One ›
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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 6ml blood collection tubes that may clot during use. This could lead to inaccurate blood test results if the tubes are used without proper anticoagulant. Affected tubes have specific lot numbers and expiration dates. Read more at govinfonow.com/recall/61950-greiner-bio-one-vacuette-6ml-blood-tubes-risk-of-clotting.

Source Summary by GovInfoNow · govinfonow.com/recall/61950-greiner-bio-one-vacuette-6ml-blood-tubes-risk-of-clotting · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2485-2021

Cite this page

“Greiner Bio-One VACUETTE 6ml Blood Tubes Risk of Clotting.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61950-greiner-bio-one-vacuette-6ml-blood-tubes-risk-of-clotting. Based on FDA recall #Z-2485-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2485-2021%22&limit=1).

Greiner Bio-One North America, Inc. voluntarily recalled VACUETTE blood collection tubes on Aug. 13, 2021, after they may experience clotting issues, according to the FDA. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: Greiner Bio-One
  • Product: VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
  • Item Number: 456279
  • Lot Codes: B21033DA (exp. 09/08/2022), B21053R8 (exp. 11/10/2022)
  • UDI Case: 39120017571248
  • UDI Rack: 29120017571241
  • Distribution: AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, VA, and Canada

The hazard

The blood collection tubes may experience a clotting issue, according to the FDA.

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) 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 pink cap with a pink ring and non-ridged design. Affected lots are B21033DA (exp. 09/2022) or B21053R8 (exp. 11/2022).

  • Brand
    Greiner Bio-One
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discard the affected tubes to prevent inaccurate blood test results.

Where it went and when

Where it was distributed

Distributed in 15 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: yesCTCalifornia: not listedCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: yesNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Colorado, Connecticut, Florida, Illinois, Maryland, Massachusetts, Michigan, Missouri, New Mexico, North Carolina, Pennsylvania, Texas, Virginia.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Aug 13, 202112. FDA classified it Class II: Sep 24, 202123. Published in FDA’s Enforcement Report: Oct 6, 202134. FDA terminated the recall: Aug 16, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-2485-2021 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2485-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA