FDA recall Z-0408-2026

Greiner Bio-One North America, Inc. · Class II · device

Product

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

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-08-08
Report date
2025-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0408-2026