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Recall Observatory FDA recall evidence

Device product

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

February 10, 2025

Class II

Product summary

Firm
Immuno-Mycologics, Inc
Event
Event 96315
Status
Ongoing
Classification
Class II
Quantity
30 vials
Official record key
device-enforcement:Z-1389-2025

Official wording

Reason: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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