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Recall Observatory FDA recall evidence

Device product

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

Z-0408-2026

August 08, 2025

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 97457
Status
Ongoing
Classification
Class II
Quantity
504,000
Official record key
device-enforcement:Z-0408-2026

Official wording

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.

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

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.