FDA Device recall Z-1454-2015
STRATIFY JCV DxSelect, Model No. EL1950
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of STRATIFY JCV DxSelect, Model No. EL1950 by Focus Diagnostics, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1454-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-15 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Focus Diagnostics |
| Distribution | n/a |
Product
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Reason
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.
Identifiers
| code_info | Lot No. 27333 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1454-2015%22
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