CLASS II Device recall · Reported 8 Feb 2017 · FDA Enforcement Report

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) recalled

Immuno-Mycologics is recalling Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003, distributed nationwide in the US. The recall was initiated on 27 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes161028133653JH, 161003111544KH, and 161007105036JG

Quantity recalled630 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1109-2017
FDA event ID: 76159
Recalling firm: Immuno-Mycologics, Norman, OK
Classification: Class II
Status: Terminated
Recall initiated: 27 Dec 2016
FDA classified: 27 Jan 2017
Reported: 8 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

27 Dec 2016	Recall initiated by company
27 Jan 2017	Classified by FDA	+31 days
8 Feb 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide throughout the US

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

161028133653JH, 161003111544KH, and 161007105036JG

Where was it sold?

Nationwide throughout the US

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Immuno-Mycologics

All 7

Reported	Class	Recall	Company	Reason	Where
6 May 2026Device	CLASS II	Immy, Myco DDR Trident, Bulk Neutralization Buffer B ( mL) recalled	Immuno-Mycologics	Other	Nationwide
26 Mar 2025Device	CLASS II	Candida ID Antigen, REAG, AG recalled by Immuno-Mycologics	Immuno-Mycologics	Other	Nationwide
9 Feb 2022Device	CLASS II	Cryptococcal Antigen Lateral Flow Assay, Immy recalled	Immuno-Mycologics	Potency & Assay	Nationwide
17 Jun 2020Device	CLASS II	Histoplasma Immunodiffusion (ID) Antigen recalled by Immuno-Mycologics	Immuno-Mycologics	Other	Nationwide
18 Jul 2018Device	CLASS II	Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) recalled	Immuno-Mycologics	Potency & Assay	OK

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