FDA Medical devices recall ·
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2% recall
- Recall number
- Z-0408-2026
- Date
- (initiated August 8, 2025)
- Company / brand
- Greiner Bio-One North America, Inc.
4238 Capital Dr, Monroe, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 504,000
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0408-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.