Device recall
Z-0513-2014: Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog…
FDA device recall · Class II · Microgenics Corp
Key facts
| Recall number (Z-number) | Z-0513-2014 |
|---|---|
| Recall event | 66626 |
| Product | Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended… |
| Product code | LFW |
| Recalling firm | Microgenics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 3, 2014 |
| 510(k) numbers | K912143 |
| FEI number | 3010939897 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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