Vacuette 456287PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 29120049204674), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 malfunction.

4 other recalls cover devices cleared under the same FDA submission (K960857); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024

  GEL BARRIER TUBES ARRIVING TO THE LAB WITH LARGE AMOUNTS OF GEL STUCK TO THE SIDES OF THE TUBES/FLOATING IN THE PLASMA RESULTING IN PERSISTENT INTERRUPTIONS TO SPECIMEN TESTING DUE TO GEL CLOGGING SAMPLING PROBES ON THE CHEMISTRY ANALYZERS. WHILE MULTIPLE LOT NUMBERS OF TUBES HAVE HAD THIS ISSUE THE CURRENT PRIMARY LOT WE ARE SEEING EXCESSIVE GEL IS LOT # B2303374. WE RECEIVED THIS LOT NUMBER FROM AT LEAST 17 PHLEBOTOMY SITES WITH GEL ISSUES OCCURRING AT EACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865232 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960857. One submission often covers many models, so check the product and lot details in each record.

• Z-0502-2022 · Dec 9, 2021 · Terminated
  greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
• Z-1081-2012 · Dec 14, 2011 · Terminated
  LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
• Z-0623-2011 · Aug 25, 2010 · Terminated
  Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.
• Z-0215-2009 · Jul 29, 2008 · Terminated
  VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufact