Immuno-Mycologics recalls specific Histoplasma Immunodiffusion antigen products due to potential false positive results from reagent contamination. Affected items include Lot L106909 with UDI # (01) 008163870:20391. No action needed if not affected.
False positive results due to potential contamination of reagent.
Immuno-Mycologics recalls certain Histoplasma antigen test kits because reagent contamination may cause false positive results. This could lead to incorrect health diagnoses if used without proper validation.
The reagent in these test kits may be contaminated, causing false positive results. This means the test might incorrectly indicate infection when there is none, leading to unnecessary health concerns or treatments.
Users of the specific Histoplasma Immunodiffusion antigen test kits with Lot number L106909 and UDI # (01) 00816387020391 are affected. Healthcare providers and labs using these kits may need to verify results.
Check for Lot number L106909 and UDI # (01) 00816387020391 on the product packaging. The affected products include Histoplasma Immunodiffusion antigen kits used in fungal antigen testing.
Verify the lot number and UDI on the packaging to confirm if your kit is affected.
No action is needed if your kit does not have Lot number L106909 or UDI # (01) 00816387020391. Only affected kits require verification.
False positive results could indicate infection when there is none, potentially causing unnecessary health concerns or treatments.
Check the lot number and UDI on the packaging. Affected kits have Lot L106909 and UDI # (01) 00816387020391.
We’ve drafted a message you can send Immuno-Mycologics to request your refund or repair — edit it as you like.
Subject: Recall Z-2301-2020 — Immuno-Mycologics Immuno-Mycologics Hello, I own a Immuno-Mycologics that is covered by recall Z-2301-2020 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.
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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.
