Meridian Bioscience recalls PREMIER Cryptococcal Antigen enzyme immunoassay kits with catalog number 602096 due to potential false negative results from unstable enzyme reagents.
An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
Meridian Bioscience is recalling PREMIER Cryptococcal Antigen enzyme immunoassay kits because the enzyme reagent may degrade over time, causing false negative test results. This could lead to incorrect diagnoses of cryptococcal infections, which are serious fungal infections that can affect the brain and spinal cord.
The enzyme reagent in the kit may degrade over time, leading to false negative results when testing patient samples. This means the test might incorrectly show no infection when one is present, potentially delaying proper treatment for serious fungal infections.
Healthcare professionals using the PREMIER Cryptococcal Antigen enzyme immunoassay kits for testing patient samples are likely affected. Those testing for cryptococcal infections in serum or cerebrospinal fluid are at risk of false negatives.
Check for the catalog number 602096 on the kit. The affected lots are 602096K089, 602096K090, and 602096K091.
Look for the lot numbers 602096K089, 602096K090, or 602096K091 on the kit packaging.
The enzyme reagent in the kit may degrade over time, leading to false negative results when testing patient samples.
A false negative means the test shows no infection when one is present, which could delay treatment for serious fungal infections like cryptococcal meningitis.
Check the catalog number 602096 and lot numbers 602096K089, 602096K090, or 602096K091 on the kit packaging.
We’ve drafted a message you can send Meridian Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0732-2019 — Meridian Bioscience Meridian Bioscience Hello, I own a Meridian Bioscience that is covered by recall Z-0732-2019 from Meridian Bioscience. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
