Device recall
Z-0064-2019: Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage…
FDA device recall · Class II · Leica Microsystems, Inc.
Key facts
| Recall number (Z-number) | Z-0064-2019 |
|---|---|
| Recall event | 80916 |
| Product | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens. |
| Product code | KPA |
| Recalling firm | Leica Microsystems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2019 |
| FEI number | 3000210133 |
At a glance
- None 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