Device recall
Z-1373-2012: Access Immunoassay Systems Assay Protocol File (APF) Software versions for…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1373-2012 |
|---|---|
| Recall event | 61118 |
| Product | Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part Number: A15518, Access 2 APF Wash Buffer REF 81907, Part Number: A45142, Access 2 APF Wash Buffer II REF A16792. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative… |
| Product code | JJE |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2012 |
| 510(k) numbers | K922823 |
| FEI number | 2050012 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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