PlainRecalls

BioReference Health, LLC

Compiled from official public sources by the publisher.

2 recalls on record · Latest: Dec 20, 2023

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Agency notice ledger

Federal filing book BioReference Health, LLC LIGHT-BOOK · SINGLE-AGENCY

#4,435 of 14,151 · 2 notices · 0.002% archive

  • BOOK 2 notices
  • RANK #4,435 of 14,151
  • SHARE 0.002% archive
  • AGENCY FDA Devices (2)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 20, 2023
  • PHOTO 3M Company

Nearest notice-volume peer: 3M Company (0 notice gap)

BioReference Health, LLC accounts for about 0.002% of the 104,423-notice archive on 2 distinct filings — a light share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

BioReference Health, LLC's standing among 14,151 recalling firms

BioReference Health, LLC ranks 4,435th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

BioReference Health, LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

2 4435th of 14151 higher than 8,037 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

BioReference Health, LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows BioReference Health, LLC holds about 0.002% of archive notices alongside 2 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Dec 20, 2023

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 patient s age, previous biopsy, and digital rectal exam (DRE).
FDA Devices Moderate Jun 14, 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 single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from

BioReference Health, LLC is a small archive contributor

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name BioReference Health, LLC? ▼
PlainRecalls indexes 2 distinct federal recall events naming BioReference Health, LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does BioReference Health, LLC sit among other recalling firms? ▼
BioReference Health, LLC ranks #4,435 of 14,151 by distinct recall-event count among 14,151 firms in this archive (57th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of BioReference Health, LLC's notices? ▼
FDA Devices accounts for 2 of this firm's 2 indexed notices.
What product category dominates BioReference Health, LLC's filing book? ▼
Filings for BioReference Health, LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
BioReference Health, LLC: 2 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming BioReference Health, LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026