Device recall
Z-0048-2012: Abbott m2000rt System software; an automated system for performing…
FDA device recall · Class II · Abbott Molecular
Key facts
| Recall number (Z-number) | Z-0048-2012 |
|---|---|
| Recall event | 59768 |
| Product | Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des Plaines, IL 60018 USA; catalog #09K15-01 The Abbott m2000rt System provides for real-time measurement… |
| Product code | OOI |
| Recalling firm | Abbott Molecular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 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