Device recall
Z-1935-2011: Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1935-2011 |
|---|---|
| Recall event | 57450 |
| Product | Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. |
| Product code | JJE |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 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