Z-0408-2026 Class II Ongoing
FDA device recall Z-0408-2026 was initiated by Greiner Bio-One North America, Inc. on August 8, 2025 and is designated Class II. 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 c… The recall status is ongoing. Affected quantity: 504,000.
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- August 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 504,000
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026