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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71059

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

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Event summary

Timeline bucket
April 22, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alere Scarborough, Inc. dba Binax, 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

Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Z-1677-2015
Recall number
Z-1677-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Quantity
213 kits plus 3 - evaluation use only kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.

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.

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Inspect official wording and provenance

Reason for recall

High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.

Code information

PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)

Distribution pattern

Worldwide Distribution - US Nationwide in the states of AL CA CT FL IA ID IL IN KY LA MD MO MS NC NE NJ OH PA SC TN TX and the countries of: Hong Kong and Singapore.