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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74113

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

Open FDA event record

Event summary

Timeline bucket
May 09, 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

Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis

Z-2040-2016
Recall number
Z-2040-2016
Initiated
May 09, 2016
Classification
Class II
Status
Terminated
Recalling firm
Immuno-Mycologics, Inc
Quantity
467 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
bacterial contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device was found to have bacterial contamination.

Code information

Lot 111WH3

Distribution pattern

Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.