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Lower risk Medical device recall · FDA · Published March 31, 2023

Greiner Bio-One VACUETTE Tubes Recall: Incorrect Labeling Risk

Greiner Bio-One recalls 1200 VACUETTE 6ml tubes with incorrect labeling. Affected units may have wrong labels causing confusion in medical use. Consumers should check labels and contact for details.

🇺🇸 FDA recall #Z-1583-2023Medical 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 1200 VACUETTE 6ml tubes that may have incorrect labels. This could cause confusion in medical use, especially for blood draws. Read more at govinfonow.com/recall/58634-greiner-bio-one-vacuette-tubes-recall-incorrect-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58634-greiner-bio-one-vacuette-tubes-recall-incorrect-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1583-2023

Cite this page

“Greiner Bio-One VACUETTE Tubes Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58634-greiner-bio-one-vacuette-tubes-recall-incorrect-labeling-risk. Based on FDA recall #Z-1583-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1583-2023%22&limit=1).

The FDA announced on March 31, 2023, that Greiner Bio-One North America, Inc. is recalling greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA due to incorrect labeling. The recall affects 36,000 pieces distributed in Wisconsin and Georgia.

How to tell if you have it

  • greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in
  • UPC: 39120017576496
  • Lot #B220533J
  • Expiration date: 2023-10-31

The hazard

Some of the tubes may be incorrectly labeled, according to the FDA.

Context

GovInfoNow's records show Greiner Bio-One North America, Inc. has had 11 other recalls since November 25, 2019. Other recent recalls of similar products include Vacuette 8ml CAT Serum Separator Clot Activator Tubes May Cause Incorrect Test Results (August 19, 2025), Greiner Bio-One VACUETTE 2ml Coagulation Tubes: Incorrect Fill Level Label May Cause Repeat Collections (August 8, 2025), and Greiner Bio-One VACUETTE Tube Recall: Clotting Issues May Delay Treatment (May 14, 2024).

How to tell if you have this one

Check for the label: 13x100 pink cap with black ring, non-ridged, 24 racks of 50 tubes. The lot number B220533J and expiration date 2023-10-31 are also on the packaging.

  • Brand
    Greiner Bio-One
  • Product
    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Labels

    Look for the label: 13x100 pink cap with black ring, non-ridged, 24 racks of 50 tubes.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of WI and GA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Georgia, Wisconsin.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Mar 31, 202312. FDA classified it Class II: May 12, 202323. Published in FDA’s Enforcement Report: May 24, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1583-2023 (March 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1583-2023 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