Z-1109-2017Class II

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

Name: Z-1109-2017 Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Creator: Immuno-Mycologics, Inc
Published: 2016-12-27
License: https://open.fda.gov/license/

IMMY, Inc. / initiated 2016-12-27 / Terminated / root cause: manufacturing process

FDA source

Immuno-Mycologics, Inc began a recall of Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 on 2016-12-27. FDA classified it as Class II and gives the reason as "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". 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-1109-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Posted: 2017-01-27
Terminated: 2017-03-08
Recalling firm: IMMY, Inc.
Product: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Product code: GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Immuno sent an Urgent: Medical Device Recall Letter dated December 27, 2016, to all affected customers. All customers were notified via emails to stop using the product on December 27th and December 28th. A recall notification and response form was attached to the email. For further questions, please call (405)364-1058.
Quantity in commerce: 630 units
Distribution: Nationwide throughout the US
Product codes and lots: 161028133653JH, 161003111544KH, and 161007105036JG

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1109-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1109-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-27

Product code GMD

K112422Class IICrag Lateral Flow Assay (Lfa)Immuno-Mycologics, Inc. / cleared 2012-03-28

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)