Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influ

FDA device recall Z-1144-2014 · posted 2014-03-05 · Terminated

Recall details

Recalling firm

Focus Diagnostics Inc

Reason for recall

Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.

Action taken

Focus Diagnostic initiated this recall on February 4, 2014 by sending recall notification letters to customers via email. The letter dated February 4, 2014, titled "URGENT: SAFETY NOTICE REMOVAL", informed customers of the recall (removal). The letter provided the following information: product description with code, reason for recall, the issue, the risk to health, recommendation, background, actions by customers, contact information, labeling, and response sheet.

Root cause

Under Investigation by firm

Status

Terminated

Product code

OOC

Quantity affected

2,175 kits

Distribution

Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.

Date initiated

2014-02-04

Date posted

2014-03-05

Date terminated

2014-11-01

Location

Cypress, CA