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.
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Immuno-Mycologics is recalling its Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) Model CR2003 because the test strips might not work properly, leading to false negative results for cryptococcosis. This could mean infections go undetected if the test is used with faulty equipment.
The test strips might not properly move liquid (wick) during use, causing the test to show no infection when one is present. This could lead to false negative results for cryptococcosis, a serious fungal infection.
Healthcare professionals and labs using the CrAg LFA Model CR2003 for cryptococcosis testing are affected. Those with the lot numbers L102802 or L103012 are most at risk.
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.
Look for lot numbers L102802 or L103012 on the CrAg LFA Model CR2003 packaging.
The test strips might not properly move liquid (wick), causing false negative results for cryptococcosis. This could miss infections.
Check the lot number on the CrAg LFA Model CR2003 packaging; affected lots are L102802 and L103012.
No, but you should check the lot number. If it's one of the affected lots, contact Immuno-Mycologics for guidance.
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 Immuno-Mycologics Hello, I own a Immuno-Mycologics 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.
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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.
