Immuno-Mycologics, Inc: Medical Device Recall in 2016 - (Recall #: Z-2040-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 9, 2016

Date Posted: June 29, 2016

Recall Number: Z-2040-2016

Event ID: 74113

Reason for Recall:

The device was found to have bacterial contamination.

Status: Terminated

Product Quantity: 467 units

Code Information:

Lot 111WH3

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated