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

Agency Publication Date: January 16, 2024

Summary

Greiner Bio-One North America is recalling 495,600 VACUETTE TUBE 4 ml blood collection tubes because they may be missing the necessary additive or anticoagulant required to prevent blood from clotting. Without these additives, blood samples collected in these tubes can clot, which may prevent lab results from being reported or lead to incorrect glucose and lactose readings. This defect could cause significant delays in medical diagnosis or lead to patients receiving inappropriate treatments based on faulty test results.

Risk

Missing additives cause blood to clot inside the tube; a partially clotted sample can produce false glucose or lactose measurements, while a fully clotted sample cannot be tested at all, potentially delaying life-saving treatment.

What You Should Do

Identify affected products by checking for VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate (Item #454297) with a grey cap and black ring.
Check the packaging for Lot #A221135N and an expiration date of 03/02/2024.
Verify the UDI-DI on the case label (39120017575130) or the rack label (29120017575133) to confirm if your supply is part of this recall.
Immediately stop using any tubes from the affected lot and set them aside to ensure they are not used for patient blood collection.
Contact your healthcare provider or Greiner Bio-One North America, Inc. directly for further instructions regarding the return or disposal of these tubes and to discuss potential refunds.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Manufacturer Notification and Guidance

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

Affected Products

Product: VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, 13x75 grey cap-black ring, non-ridged (Item #454297)

Model / REF:

Item #454297

UDI-DI Case label 39120017575130

UDI Rack label 29120017575133

Lot Numbers:

A221135N

Date Ranges: Exp. date 03/02/2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93606

Status: Active

Manufacturer: Greiner Bio-One North America, Inc.

Sold By: Medical distributors; Healthcare facilities

Manufactured In: United States

Units Affected: 495,600 tubes

Distributed To: Connecticut, Florida, Iowa, Illinois, Missouri, North Carolina, New York, Pennsylvania, Tennessee, Virginia

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 affected products by checking for VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate (Item #454297) with a grey cap and black ring.

Check the packaging for Lot #A221135N and an expiration date of 03/02/2024.

Verify the UDI-DI on the case label (39120017575130) or the rack label (29120017575133) to confirm if your supply is part of this recall.

Immediately stop using any tubes from the affected lot and set them aside to ensure they are not used for patient blood collection.

Contact your healthcare provider or Greiner Bio-One North America, Inc. directly for further instructions regarding the return or disposal of these tubes and to discuss potential refunds.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).