Elmwood Park, NJ, United States
BioReference Health, LLC recalls
2 recalls recorded since 2018, most recently on 31 October 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 October 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0516-2024
- 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 s
Ongoing Class II Medical devices
- Recall started
- 18 November 2022
- Reason
- SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
- Distribution
- US Nationwide distribution in the state of New Jersey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1676-2023
- The 4Kscore Test is 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.