FDA Device recall Z-1923-2016
4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluo…
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluo… by Greiner Bio One North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1923-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-26 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Greiner Bio One North America |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot A151137L |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1923-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.