Device recall
Z-2169-2014: 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid…
FDA device recall · Class II · Abbott Molecular
Key facts
| Recall number (Z-number) | Z-2169-2014 |
|---|---|
| Recall event | 68617 |
| Product | 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the… |
| Product code | JJH |
| Recalling firm | Abbott Molecular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 23, 2016 |
| 510(k) numbers | K092705 |
| FEI number | 3005248192 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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