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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67436

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 04, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Focus Diagnostics Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-1144-2014
Initiated
February 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
Focus Diagnostics Inc
Quantity
2,175 kits

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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.