Immuno-Mycologics, Inc: Medical Device Recall in 2017 - (Recall #: Z-1109-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

Product Classification:

Class II

Date Initiated: December 27, 2016

Date Posted: February 8, 2017

Recall Number: Z-1109-2017

Event ID: 76159

Reason for Recall:

The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.

Status: Terminated

Product Quantity: 630 units

Code Information:

161028133653JH, 161003111544KH, and 161007105036JG

Distribution Pattern:

Nationwide throughout the US

Voluntary or Mandated:

Voluntary: Firm initiated