Immuno-Mycologics Recalls Histoplasma ID Antigen Due to Contamination
Immuno-Mycologics is recalling 155 vials of Histoplasma ID Antigen because potential reagent contamination may cause false positive test 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, and the hazard involves potential false positive results due to contamination, which is a moderate risk without reported injuries or hospitalizations.
Plain-English summary
Immuno-Mycologics, Inc. is recalling 155 vials of Histoplasma Immunodiffusion (ID) Antigen. The recall is due to potential contamination of the reagent, which may result in false positive test results. The affected product is identified by lot number L106909 and UDI # (01) 00816387020391 (17) 220610(10)L106909.
The product was distributed worldwide, including nationwide in the United States and in specific states such as AZ, CA, FL, IL, IN, MI, MN, NY, TX, UT, VA, and WI. International distribution included France, Spain, Hong Kong, and the United Kingdom. The recall is classified as Class II by the FDA.
Healthcare facilities and laboratories should stop using the affected lot and contact the manufacturer for instructions on return or replacement. Users should verify lot numbers against the recall notice to ensure they are not using the affected product.
The recalled product
- Product
- Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
- Manufacturer
- Immuno-Mycologics, Inc
- Affected units
- 155
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 (2)
- Lot number L106909
- UDI # (01) 00816387020391 (17) 220610(10)L106909
Distribution
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