Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
FDA Recall Z-1144-2014 · Posted 2014-03-05
Advertisement
Recalling FirmFocus Diagnostics Inc
Recall StatusTerminated
Product CodeOOC
Date Initiated2014-02-04
Date Terminated2014-11-01
Product Quantity2,175 kits
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.
Firm Action
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
Distribution Pattern
Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement