Device recall
Z-1243-2012: COULTER LH 500 Series System, part number: LH500 System Help 2A4.103271; LH 500…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1243-2012 |
|---|---|
| Recall event | 61255 |
| Product | COULTER LH 500 Series System , part number: LH500 System Help 2A4.103271; LH 500 Series System 100V, PN 178832; LH 500 Series System 120V, PN 178833; LH 500 Series System 240V, PN 178834; LH 500 Series System Remanufactured (115V), PN A91062; LH 500 Series System Remanufactured (220V), PN A90994 SW… |
| Product code | GKZ |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 2, 2014 |
| 510(k) numbers | K032000 |
| 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