STRATIFY JCV DxSelect — Class II medical device recall Z-1454-2015
Terminated recall by Focus Diagnostics Inc, reported 2015-04-29. Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manu
| Recall number | Z-1454-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Focus Diagnostics Inc, Cypress, CA, United States |
| Recall initiated | 2015-03-15 |
| Classified | 2015-04-17 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-07-23 |
| Countries outside the US | DK |
| Quantity | 300 units |
| Lot numbers | 27333 |
| Model numbers | EL1950 |
Product
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Reason for recall
Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1454-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.