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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85368

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

Open FDA event record

Event summary

Timeline bucket
November 04, 2019
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 Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen

Z-2301-2020
Recall number
Z-2301-2020
Initiated
November 04, 2019
Classification
Class II
Status
Terminated
Recalling firm
Immuno-Mycologics, Inc
Quantity
155 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
False positive results due to potential contamination of reagent.

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

False positive results due to potential contamination of reagent.

Code information

Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.

Field note

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