Medical device recalls Moderate risk

Greiner Bio-One North America, Inc. recalls Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Recall date
August 8, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0408-2026
FDA classification
Class II
Brand / firm
Greiner Bio-One North America, Inc.
Sold / distributed
US Nationwide distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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