Z-1454-2015Class II

STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or...

Name: Z-1454-2015 STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or...
Creator: Focus Diagnostics Inc
Published: 2015-03-15
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2015-03-15 / Terminated / root cause: manufacturing process

FDA source

Focus Diagnostics Inc began a recall of STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic on 2015-03-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1454-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-15
Posted: 2015-04-17
Terminated: 2015-07-23
Recalling firm: DiaSorin Molecular LLC
Product: STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Product code: OYP Anti-Jcv Antibody Detection Assay
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Focus Diagnostics sent an Urgent Device Customer Notification letter dated March 15, 2015, was sent to the customer to inform them that Focus Diagnostics is recalling the Stratify JCV DxSelect (EL1950) lot#27333 due to the potential for false positive JCV results. The letter informs the customer of the issues and the actions to be taken. The customer is instructed to complete the enclosed acknowledgement form and email the form to [email protected] or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. If the customer has any questions or require additional information, then they are instructed to contact Focus Diagnostic's Technical Services department at (800) 838-4548, select option 3, between the hours of 7am to 5pm (PST) or send an email to [email protected].
Quantity in commerce: 300 units
Distribution: Internationally: Denmark only.
Product codes and lots: Lot No. 27333

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1454-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1454-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-17

Product code OYP

K120986Class IIStratify Jcv DxselectFocus Diagnostics, Inc. / cleared 2012-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)