Exact FDA event identifier

Event 96315

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

Open FDA event record

Event summary

Timeline bucket: February 10, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
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

Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE

Z-1389-2025

Recall number: Z-1389-2025
Initiated: February 10, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Immuno-Mycologics, Inc
Quantity: 30 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

Code information

Lot #: F4171005/UDI: 00816387020223

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.