Device recall
Z-1923-2016: 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic…
FDA device recall · Class II · Greiner Bio-One North America, Inc.
Key facts
| Recall number (Z-number) | Z-1923-2016 |
|---|---|
| Recall event | 74002 |
| 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 |
| Product code | JKA |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2016 |
| 510(k) numbers | K971239 |
| FEI number | 3001451379 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database