Greiner Bio-One North America, Inc.: VACUETTE Blood Collection Tubes Recalled for Missing Chemical Additive

Agency Publication Date: July 17, 2024

Summary

Greiner Bio-One North America, Inc. is recalling approximately 1,008,000 VACUETTE 8 ml Serum Separator Clot Activator tubes because some tubes may be missing the necessary chemical additive. The missing additive can cause blood samples to clot improperly or fail to separate, which could lead to inaccurate lab results. If the defect is discovered during testing, a healthcare provider will likely need to draw your blood again, which could delay your diagnosis or medical treatment.

Risk

The absence of the clot activator additive prevents the blood sample from processing correctly in the laboratory. This defect necessitates a repeat blood draw, potentially delaying critical medical decisions and treatment for patients.

What You Should Do

Identify if you have the affected VACUETTE 8 ml CAT Serum Separator Clot Activator tubes by checking for Item Number 455071P and Lot Number B24013MV.
Look for the physical characteristics of the tube: it features a red cap with a yellow ring and has a non-ridged (smooth) surface.
Verify the UDI (Unique Device Identifier) numbers on the packaging; affected Case labels are 39120017573068 and Rack labels are 29120017573061.
Stop using these specific tubes immediately and quarantine any remaining stock to prevent further use in patient blood draws.
Contact Greiner Bio-One North America, Inc. or your healthcare provider for instructions on returning the affected product and obtaining replacements.
For additional information, contact the FDA directly at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer or Healthcare Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 (red cap-yellow ring, non-ridged)

Model / REF:

Item Number: 455071P

Lot Numbers:

B24013MV

UDI Case label: 39120017573068

UDI Rack label: 29120017573061

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94817

Status: Active

Manufacturer: Greiner Bio-One North America, Inc.

Sold By: Nationwide distributors; Medical facilities

Manufactured In: United States

Units Affected: 1,008,000pcs (840 cartons)

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected VACUETTE 8 ml CAT Serum Separator Clot Activator tubes by checking for Item Number 455071P and Lot Number B24013MV.

Look for the physical characteristics of the tube: it features a red cap with a yellow ring and has a non-ridged (smooth) surface.

Verify the UDI (Unique Device Identifier) numbers on the packaging; affected Case labels are 39120017573068 and Rack labels are 29120017573061.

Stop using these specific tubes immediately and quarantine any remaining stock to prevent further use in patient blood draws.

Contact Greiner Bio-One North America, Inc. or your healthcare provider for instructions on returning the affected product and obtaining replacements.

For additional information, contact the FDA directly at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.