Class II — Greiner Bio-One North America, Inc.
| Recalling firm | GREINER BIO-ONE NA |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 |
| Quantity | 504,000 |
| Distribution | US Nationwide distribution. |
| Initiated | 2025-08-08 |
| Classified | 2025-10-28 |
| Recall number | Z-0408-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Greiner Bio-One North America, Inc. (Z-0408-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97457/
Alerts for GREINER BIO-ONE NA
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.