The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total
FDA device recall Z-1676-2023 · posted 2023-06-02 · Open, Classified
Recall details
- Recalling firm
- BioReference Health, LLC
- Reason for recall
- SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
- Action taken
- 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.
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- QRF
- Quantity affected
- 1 system (662 Patients test results affected)
- Distribution
- US Nationwide distribution in the state of New Jersey.
- Date initiated
- 2022-11-18
- Date posted
- 2023-06-02
- Location
- Elmwood Park, NJ
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