Device recall
Z-0315-2025: intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer…
FDA device recall · Class II · Biocare Medical, LLC
Key facts
| Recall number (Z-number) | Z-0315-2025 |
|---|---|
| Recall event | 95481 |
| Product | intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number… |
| Product code | PPM |
| Recalling firm | Biocare Medical, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 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