FDAClass IINovember 5, 2025

Greiner Bio-one Vacuette recall

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Why was Greiner Bio-one Vacuette recalled?

Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026

Product
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Recalling firm
Greiner Bio-One North America, Inc.
Quantity
504,000
Distribution
US Nationwide distribution.
Recall date
November 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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