FDA-Device2025-11-05Class II

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

Greiner Bio-One North America, Inc.
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
504,000
Manufactured in
4238 Capital Dr, N/A, Monroe, NC, United States
Products
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Official notice

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

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