4Kscore Test 1Recalls & reported problems
Bioreference Health, LLC · 4Kscore Specimen Collection Kit · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850038860004), received between Apr 17, 2023 and Apr 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Version or Upgrade Problem” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 31, 2023Open, Classified
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.
Z-0516-2024 · Root cause: Device Design · FDA record ↗
- Nov 18, 2022Open, Classified
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Z-1676-2023 · Root cause: Software Design Change · FDA record ↗
Most reported problems
Device problems
- Application Program Version or Upgrade Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2023Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem
A 67-YEAR OLD MALE WITH A HISTORY OF HIGH LEVEL OF PROSTATE SPECIFIC ANTIGEN (PSA), SUBMITTED A SAMPLE FOR 4KSCORE TEST ANALYSIS ON (B)(6) 2022, WHICH WAS CONDUCTED ON (B)(6) 2022. THE SUBJECT'S UROLOGICAL HISTORY INCLUDED A PREVIOUS DIGITAL RECTAL EXAM WITHOUT A PROSTATE NODULE PRESENT. THE SUBJECT ALSO HAD A PREVIOUS BIOPSY THAT WAS NEGATIVE. HIS 4KSCORE WAS CALCULATED AS 27.3, WHICH WAS REPORTED TO THE REQUISTIONER/PROVIDER ON (B)(6) 2022. GIVEN THE IDENTIFICATION OF THE INPUT ERROR IN THE SAMPLE REQUISITION INTAKE SOFTWARE, HIS 4KSCORE WAS RECALCULATED ON (B)(6) 2022, WITH A REVISED 4KSCORE OF 5.6, 16 DAYS POST THE INITIAL RESULT. THE SUBJECT HAD NO OUTCOME SPECIFIED. GIVEN THAT THE INITIAL 4KSCORE RESULT WAS GREATER THAN 20 AND DECREASED UPON RECALCULATION, IT IS POSSIBLE THAT THE SUBJECT WAS SUBJECTED TO ADDITIONAL AND POTENTIALLY UNNECESSARY MEDICAL PROCEDURES WHICH MAY INCLUDE MAGNETIC RESONANCE IMAGING OF THE PROSTATE AND/OR BIOPSY AND THE RISKS ASSOCIATED WITH THAT, AS DEEMED NECESSARY BY THE ATTENDING PHYSICIAN. TO DATE, THE SPONSOR HAS NOT RECEIVED OR IS AWARE OF ANY UNTOWARD EVENTS/EFFECTS AS A RESULT OF THIS DEVICE MALFUNCTION AND ERRANT INITIAL 4KSCORE TEST RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16756621 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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