Device recall
Z-2208-2010: Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is…
FDA device recall · Class III · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2208-2010 |
|---|---|
| Recall event | 55678 |
| Product | Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems. |
| Product code | JJX |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 7, 2012 |
| 510(k) numbers | K981864 |
| 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