VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate — Class II medical device recall Z-0733-2024
Ongoing recall by Greiner Bio-One North America, Inc., reported 2024-01-24, distributed nationwide. Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample wou
| Recall number | Z-0733-2024 |
|---|---|
| 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 | 2023-12-12 |
| Classified | 2024-01-16 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 495,600 tubes |
| UPC / GTIN / UDI-DI | 29120017575133, 39120017575130 |
| Lot numbers | A221135N |
| Model numbers | 13X75, 454297 |
| Expiration dates | 2024-03-02 |
Product
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Reason for recall
Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
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-0733-2024. 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.