Device recall
Z-2227-2012: Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the…
FDA device recall · Class III · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2227-2012 |
|---|---|
| Recall event | 62791 |
| Product | Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL. |
| Product code | CDP |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 14, 2013 |
| 510(k) numbers | K940833, K955435 |
| 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