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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76159

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

Open FDA event record

Event summary

Timeline bucket
December 27, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Immuno-Mycologics, 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

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

Z-1109-2017
Recall number
Z-1109-2017
Initiated
December 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
Immuno-Mycologics, Inc
Quantity
630 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.

Code information

161028133653JH, 161003111544KH, and 161007105036JG

Distribution pattern

Nationwide throughout the US