Recall Z-0408-2026— Greiner Bio-One North America, Inc.

Name: FDA recall Z-0408-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-08

Class II · Ongoing

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2025-08-08. It names one FDA 510(k) clearance: K971221. Product: Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322. Reason: 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..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-08
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K971221 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·cleared 1997-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.