Device recall
Z-1333-2021: BIOCARE Medical, IntelliPath FLX, Automated Staining Instrument, Ref: " Model…
FDA device recall · Class II · Biocare Medical, LLC
Key facts
| Recall number (Z-number) | Z-1333-2021 |
|---|---|
| Recall event | 87426 |
| Product | BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 |
| Product code | KPA |
| Recalling firm | Biocare Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2023 |
| FEI number | 3004140393 |
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