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Recall Observatory FDA recall evidence

Device product

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.

Z-1144-2014

February 04, 2014

Class II

Product summary

Firm
Focus Diagnostics Inc
Event
Event 67436
Status
Terminated
Classification
Class II
Quantity
2,175 kits
Official record key
device-enforcement:Z-1144-2014

Official wording

Reason: 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.

Code information: Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.