Aniara Diagnostica recalls ZYMUTEST HIA IgG ELISA kits with lot number FD1265 due to outdated positive control values in the test instructions.
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Aniara Diagnostica is recalling ZYMUTEST HIA IgG ELISA kits from lot FD1265 because the test instructions contained incorrect positive control values. This could lead to inaccurate test results if used without the updated instructions.
The kit's instructions included outdated positive control values from October 8, 2024, which could cause incorrect test results. This error may lead to misdiagnosis if the test is used without the updated instructions.
Users of the ZYMUTEST HIA IgG ELISA kit with lot number FD1265 are affected. Laboratory staff and healthcare providers who use the kit for diagnostic testing are most at risk of inaccurate results.
Check for the lot number FD1265 on the kit's packaging. The product was packaged on October 17, 2024, and sold with an outdated flyer from October 8, 2024.
Look for the lot number FD1265 on the kit's packaging to confirm if it is affected.
The kit's instructions contained outdated positive control values from October 8, 2024, which could cause incorrect test results.
Check for the lot number FD1265 on the kit's packaging. The product was packaged on October 17, 2024, and sold with an outdated flyer from October 8, 2024.
The official recall does not provide a remedy or fix for this issue.
We’ve drafted a message you can send Aniara Diagnostica to request your refund or repair — edit it as you like.
Subject: Recall Z-2171-2026 — Aniara Diagnostica Aniara Diagnostica Hello, I own a Aniara Diagnostica that is covered by recall Z-2171-2026 from Aniara Diagnostica. 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.
