Device recall
Z-1606-2011: MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in…
FDA device recall · Class III · Fujirebio Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1606-2011 |
|---|---|
| Recall event | 56427 |
| Product | MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in… |
| Product code | OAW |
| Recalling firm | Fujirebio Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 5, 2012 |
| FEI number | 2521625 |
At a glance
- None 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