Device recall
Z-2125-2013: Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage…
FDA device recall · Class I · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-2125-2013 |
|---|---|
| Recall event | 66058 |
| Product | Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. |
| Product code | LON |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 15, 2014 |
| 510(k) numbers | K020246, K020249 |
| FEI number | 2919016 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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