Device recall
Z-2215-2011: Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2215-2011 |
|---|---|
| Recall event | 57469 |
| Product | Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin… |
| Product code | MSW |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2012 |
| 510(k) numbers | K002905, K031269 |
| FEI number | 2050012 |
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