--- title: "BioReference Health, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search BioReference Health, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/bioreference-health-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # BioReference Health, LLC recall records **2** reported ongoing 2 records in this archive. Latest source date Oct 31, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Oct 31, 2023 FDA device enforcement ### [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, i...](https://isitonrecall.com/recall/fda-device-z-0516-2024-the-4kscore-test-an-in-vitro-serum-or-plasma-test-that-combines-the-results-of-four-immunoassays-roc/) 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. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0516-2024%22) Nov 18, 2022 FDA device enforcement ### [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,...](https://isitonrecall.com/recall/fda-device-z-1676-2023-the-4kscore-test-is-an-in-vitro-serum-or-plasma-test-that-combines-the-results-of-four-immunoassays/) SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results Class II Reported ongoing Distribution: US Nationwide distribution in the state of New Jersey. [Official source for The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1676-2023%22) ## Reasons in these listed records - 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. - SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results These examples come from this result page and are not a ranking of every recall reason. ## Checking BioReference Health, LLC ### Is there a recall on bioreference health, llc right now? This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search BioReference Health, LLC](https://isitonrecall.com/check/?q=BioReference%20Health%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)