Z-2040-2016Class II

Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls...

Name: Z-2040-2016 Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls...
Creator: Immuno-Mycologics, Inc
Published: 2016-05-09
License: https://open.fda.gov/license/

IMMY, Inc. / initiated 2016-05-09 / Terminated / root cause: manufacturing process

FDA source

Immuno-Mycologics, Inc began a recall of Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by... on 2016-05-09. FDA classified it as Class II and gives the reason as "The device was found to have bacterial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2040-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Posted: 2016-06-20
Terminated: 2017-01-10
Recalling firm: IMMY, Inc.
Product: 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 code: GMJ Antigens, Histoplasma Capsulatum, All
Reason for recall: The device was found to have bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Immuno-Mycologics, Inc sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their stock and destroy affected stock on hand. Immediately complete the attached Acknowledgement and Receipt Form even if they do not have affected stock. Customers who require replacement indicate the number of vials needed in the attached Acknowledgement Form. Customers with questions were instructed to call 1-405-360-4669.
Quantity in commerce: 467 units
Distribution: Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Product codes and lots: Lot 111WH3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2040-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2040-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-20

Product code GMJ

K791393Class IIHistoplasma Yeast Anti #Cf10021xImmuno-Mycologics, Inc. / cleared 1979-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)