Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3 — Class II medical device recall Z-0408-2026
Ongoing recall by Greiner Bio-One North America, Inc., reported 2025-11-05, distributed nationwide. Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printe
| Recall number | Z-0408-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greiner Bio-One North America, Inc., Monroe, NC, United States |
| Recall initiated | 2025-08-08 |
| Classified | 2025-10-28 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 504,000 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 29120017574488, 39120017574485 |
| Lot numbers | B250139Q |
| Model numbers | 454322 |
| Expiration dates | 2026-01-09 |
Product
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0408-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.