Exact FDA event identifier

Event 72395

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

Open FDA event record

Event summary

Timeline bucket: October 02, 2015
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

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

Z-0238-2016

Recall number: Z-0238-2016
Initiated: October 02, 2015
Classification: Class II
Status: Terminated
Recalling firm: Focus Diagnostics Inc
Quantity: 38 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.

Code information

26341, 27011

Distribution pattern

Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia