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U.S. Department of Health and Human Services

Class 2 Device Recall The 4Kscore Test

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  Class 2 Device Recall The 4Kscore Test see related information
Date Initiated by Firm November 18, 2022
Date Posted June 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-1676-2023
Recall Event ID 92205
PMA Number P190022 
Product Classification Multi-analyte test system with algorithmic analysis for detection of prostate cancer - Product Code QRF
Product 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 the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.
Code Information UDI: 00850038860004
Recalling Firm/
Manufacturer		 BioReference Health, LLC
481 Edward H Ross Dr
Elmwood Park NJ 07407-3118
For Additional Information Contact
800-229-5227
Manufacturer Reason
for Recall		 SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
FDA Determined
Cause 2		 Software Design Change
Action Customers were notified via telephone between 11/18/22 and 12/31/22. In addition, the following information was provided within the corrected test results sent to customers: The 4Kscore result has been corrected to reflect the history of a prostatic nodule and/or the prior negative biopsy result, which was inaccurately posted into the algorithm, due to a bioinformatics error.
Quantity in Commerce 1 system (662 Patients test results affected)
Distribution US Nationwide distribution in the state of New Jersey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = QRF and Original Applicant = OPKO Health, Inc.
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