Device recall
Z-1949-2011: Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1949-2011 |
|---|---|
| Recall event | 58169 |
| Product | Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems… |
| Product code | KLI |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2012 |
| 510(k) numbers | K023369 |
| 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