Device recall
Z-2310-2016: AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-2310-2016 |
|---|---|
| Recall event | 74568 |
| Product | AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories. |
| Product code | JJE |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2017 |
| 510(k) numbers | K112412 |
| 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