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

FDA device recall Z-1454-2015 · posted 2015-04-17 · Terminated

Recall details

Recalling firm

Focus Diagnostics Inc

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.

Action taken

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 DxTS@focusdx.com 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 DxTS@focusdx.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OYP

Quantity affected

300 units

Distribution

Internationally: Denmark only.

Date initiated

2015-03-15

Date posted

2015-04-17

Date terminated

2015-07-23

Location

Cypress, CA

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