FDA-Device2025-11-05Class IIPACKAGING DEFECT

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

LABEL MIX UPNationwide distributionMedical devices
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.

Intended for
All ages
Illnesses reported
None reported
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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