Reported Nov 26, 2025 · Ongoing

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product…

Greiner Bio-One North America, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Greiner Bio-One North America, Inc. · 4238 Capital Dr · Monroe, NC · 28110-7681

Is this the product you have?

  • Brand NameVacuette
  • Product Name8 ml CAT Serum Separator
  • Clot Activator Model/Catalog Number455071P
  • Product DescriptionGreiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
Lot codes and dates
  • Lot CodeLot/Serial
  • NumbersItem# 455071P Lot#
  • B250437N UDI-DI code29120017573061
Amount recalled
1,980,000

Where it was sold

Why it was recalled

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.