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 | Terminated |
| 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. |
| 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 |
| Quantity | 250,800 pieces (209 cases) |
| Distribution | Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico |
| Initiated | 2016-04-26 |
| Classified | 2016-06-07 |
| Terminated | 2016-08-22 |
| Recall number | Z-1923-2016 |
| 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-1923-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74002/
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