Class 2 Device Recall The 4Kscore Test

• Date Initiated by Firm: October 31, 2023
• Date Posted: December 08, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0516-2024
• Recall Event ID: 93050
• PMA Number: P190022
• Product Classification: Multi-analyte test system with algorithmic analysis for detection of prostate cancer - Product Code QRF
• Product: 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).
• Code Information: UDI-DI: 00850038860004
• Recalling Firm/ Manufacturer: BioReference Health, LLC; 481 Edward H Ross Dr; Elmwood Park NJ 07407-3118
• For Additional Information Contact: 833-457-2673
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: A notification letter dated 10/31/23 was sent to customers. As of the FDA approval of 4Kscore in December 2021, only results with a digital rectal examination (DRE) input of Nodule or No Nodule are considered as valid. Customers who received 4Kscore results without having DRE information inputted (e.g., no information entered for Nodule or No Nodule ) are advised that these results may have increased uncertainty, potentially resulting in erroneous decision interpretations, as DRE information is required for the interpretation recommendations contained in the PMA approved device labeling. The device has now been modified such that if the required DRE information is not provided (e.g., no information entered for Nodule or No Nodule ), then the blood sample will be frozen and stored at our laboratory for up to 60 days, and 4Kscore results will not be performed unless the required DRE information is provided within 60 days. As per the package insert, the DRE cannot be performed within 96 hours before sample collection, but it can be performed after phlebotomy, or in the preceding 12 months before testing. If it is more convenient to schedule the DRE in an office visit after the blood draw, blood samples will be frozen and stored at our laboratory for up to 60 days. The required DRE information can be provided to our customer service center within that ¿¿me, and the sample will be tested once this information is received. No results will be reported if the input of Nodule or No Nodule information is not received by 60 days. If there are any questions, please feel free to reach out by telephone: 1-833-4KSCORE (1-883-457-2673), Fax: 201-663-4113, or email: 4kcustomerservice@bioreference.com. Thank you again for allowing BioReference Health to assist you in the care of your patients with potential prostate cancer. Please respond using the page following this letter, by fax 201-663-4113, or email: 4kcustomerservice@bioreference.com to confirm receipt of thi
• Quantity in Commerce: 1 system (3,196 tests)
• Distribution: US Nationwide distribution.
• 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.