Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 14, 2023
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
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
BioReference Health, LLC recalled The 4Kscore Test is an in vitro serum or plasma test that combines the results of four im… - a moderate-severity action.
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four im… was recalled by BioReference Health, LLC in June 14, 2023. Reason: SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results. Check the official notice for the remedy. Verify recall #Z-1676-2023 with the FDA Devices before acting.
The recall
BioReference Health, LLC issued this moderate-severity FDA Devices recall-SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results.
- Moderate
- severity level
- Class II
- classification
- June 14, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1676-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1676-2023) was formally reported on June 14, 2023, with the manufacturer initiating the action on November 18, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. BioReference Health, LLC is listed as the recalling firm, operating out of Elmwood Park, NJ. Federal records list the affected scope as 1 system (662 Patients test results affected).
The documented reason for this recall is: SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of New Jersey.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1 system (662 Patients test results affected)
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1676-2023 |
| Date reported | June 14, 2023 |
| Date initiated | November 18, 2022 |
| Recalling firm | BioReference Health, LLC |
| Firm location | Elmwood Park, NJ |
| Affected scope | 1 system (662 Patients test results affected) |
| Distribution | US Nationwide distribution in the state of New Jersey. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1676-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BioReference Health, LLC. Units affected: 1 system (662 Patients test results affected).
Why was this product recalled? ▼
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1676-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of New Jersey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1676-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 14, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.