The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total P
Summary
The FDA issued a Class II for The 4Kscore Test, an in vitro serum or plasma test that combines the results of by BioReference Health, LLC. Reason: Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required c.
Details
Source
Device Recall
External ID
Z-0516-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
Product Description
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).
Lot/Code Info: UDI-DI: 00850038860004
Quantity Affected: 1 system (3,196 tests)
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-31
Company
Elmwood Park, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioReference Health, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioReference Health, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioReference Health, LLC have FDA actions?
BioReference Health, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0516-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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