Lower riskMedical device recall · FDA · Published March 30, 2018
Immuno-Mycologics CrAg LFA Model CR2003: False Negative Cryptococcosis Test Risk
Immuno-Mycologics recalls Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) Model CR2003 due to potential false negative results in cryptococcosis testing. Affected lots L102802 and L103012.
“Immuno-Mycologics CrAg LFA Model CR2003: False Negative Cryptococcosis Test Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71567-immuno-mycologics-crag-lfa-model-cr2003-false-negative-cryptococcosis-test. Based on FDA recall #Z-2409-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2409-2018%22&limit=1).
The FDA announced on March 30, 2018, that Immuno-Mycologics, Inc. recalled the Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003, due to a potential for false negative test results. The agency issued the recall notice regarding the Class II device on that date.
The hazard involves the potential for LFA strips to improperly wick, which may cause false negative cryptococcosis test results. The device is used for detecting capsular polysaccharide antigens of Cryptococcus species complex in serum and cerebral spinal fluid.
Context
GovInfoNow's records show Immuno-Mycologics, Inc. has had four other recalls since November 4, 2019. Other recent recalls include the Immuno-Mycologics Immy Neutralization Buffer Recall on March 26, 2026, and the Immuno-Mycologics Candida ID Antigen Recall on February 10, 2025. Similar product recalls include the Meridian Bioscience Revogene C. difficile Test Recall reported on December 5, 2025.
How to tell if you have this one
Check if you have the CrAg LFA Model CR2003 with lot numbers L102802 or L103012. This product is used for lab testing of cryptococcosis in serum or spinal fluid.
Brand
Immuno-Mycologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot numbers L102802 or L103012 on the CrAg LFA Model CR2003 packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Take action
Contact Immuno-Mycologics
We’ve drafted a message you can send Immuno-Mycologics to request your refund or repair — edit it as you like.
Subject: Recall Z-2409-2018 — Immuno-Mycologics CrAg LFA Model CR2003: False Negative Cryptococcosis Test Risk
Hello,
I own a Immuno-Mycologics CrAg LFA Model CR2003: False Negative Cryptococcosis Test Risk that is covered by recall Z-2409-2018 from Immuno-Mycologics.
I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?
Thank you.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2409-2018 (March 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2409-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.