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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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