Device recall
Z-0773-2012: Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd…
FDA device recall · Class II · Microgenics Corp
Key facts
| Recall number (Z-number) | Z-0773-2012 |
|---|---|
| Recall event | 60503 |
| Product | Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064. .Tobramycin is a commonly used antibiotic to treat bacterial infections, in particular gram negative infections. |
| Product code | DLJ |
| Recalling firm | Microgenics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 9, 2012 |
| 510(k) numbers | K872349 |
| 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