Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Due to False Positives
Immuno-Mycologics is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay because specific lots have lower specificity, leading to reported false positive results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves false positive results which may lead to unnecessary medical interventions, but no direct physical injury or death is reported in the source text, fitting the Moderate criteria for low-risk contamination or labeling/performance errors without reported severe harm.
Plain-English summary
Immuno-Mycologics, Inc is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003. The recall covers lots with codes 161028133653JH, 161003111544KH, and 161007105036JG, which were distributed nationwide throughout the US.
The recall was initiated because the affected products have approximately 91% specificity, compared to approximately 99% specificity for non-affected lots. This reduced specificity has resulted in false positive test results. The recalling firm is aware of three customers who reported these false positive results.
Healthcare providers and customers should stop using the affected lots and contact Immuno-Mycologics, Inc for further instructions or a replacement.
The recalled product
- Product
- Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
- Manufacturer
- Immuno-Mycologics, Inc
- Hazard
- Affected units
- 630
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 161028133653JH
- 161003111544KH
- and 161007105036JG
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Immuno-Mycologics, Inc
See all →- SevereImmy Myco DDR Trident Neutralization Buffer B Recalled for Potential Contamination
FDA (Devices) · 2026-05-06
- HighCandida ID Antigen recalled for reduced sensitivity, potential false negatives
FDA (Devices) · 2025-03-26
- HighCryptococcal Antigen Test Kits Recalled for Reduced Detection Specificity
FDA (Devices) · 2022-02-09
- ModerateImmuno-Mycologics Recalls Histoplasma ID Antigen Due to Contamination
FDA (Devices) · 2020-06-17
- HighImmuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Strips
FDA (Devices) · 2018-07-18
Same hazard · false positive
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma calibrators recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11