Class II
Medical Device Recall: Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Greiner Bio-One North America, Inc. · August 8, 2025
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
504,000
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0408-2026
Status: ongoing
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