← FDA ENFORCEMENT
Z-0408-2026Class II

Greiner Bio-One North America, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Greiner Bio-One North America, Inc.
Product type
Device
Status
Ongoing
Report date
2025-11-05
Distribution
US Nationwide distribution.
Firm state
NC
Product quantity
504,000
Initiated by
Voluntary: Firm initiated
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.

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →