Device recall
Z-0516-2024: The 4Kscore Test, an in vitro serum or plasma test that combines the results of…
FDA device recall · Class II · BioReference Health, LLC
Key facts
| Recall number (Z-number) | Z-0516-2024 |
|---|---|
| Recall event | 93050 |
| Product | The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a… |
| Product code | QRF |
| Recalling firm | BioReference Health, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P190022 |
| FEI number | 3003652672 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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