4 ml FX Sodium Fluoride/Potassium Oxalate tube — Class II medical device recall Z-1923-2016
Terminated recall by Greiner Bio-One North America, Inc., reported 2016-06-15, distributed nationwide. The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium
| Recall number | Z-1923-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greiner Bio-One North America, Inc., Monroe, NC, United States |
| Recall initiated | 2016-04-26 |
| Classified | 2016-06-07 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2016-08-22 |
| Distributed | Nationwide (US) |
| Lot numbers | A151137L |
| Model numbers | 454297 |
Product
4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate
Reason for recall
The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.
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-1923-2016. 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.