FDA-Device2014-03-12Class II
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.
Focus Diagnostics Inc
Hazard
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.
Sold states
Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
Affected count
2,175 kits
Manufactured in
11331 Valley View St, Cypress, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1144-2014Don't want to check this manually?
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