Drug recall
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche…
FDA recall event 93050 · Class II · BioReference Health, LLC
Key facts
| Event ID | 93050 |
|---|---|
| Recall numbers | Z-0516-2024 |
| Recalling firm | BioReference Health, LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test. |
| Initiation date | Oct 31, 2023 |
| Report date | Dec 20, 2023 |
| City | Elmwood Park |
| State | NJ |
| Country | United States |
| FEI number | 3003652672 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: