Aniara Diagnostica recalls ZYMUTEST HIA MonoStrip IgG ELISA kits (Model RK041A) due to residual crystallization causing negative controls to go out of range. Affected kits sold under specific serial numbers.
Residual crystallization of the microplate and recurrent negative controls out of range.
Ani: Aniara Diagnostica is recalling ZYMUTEST HIA MonoStrip IgG ELISA kits (Model RK041A) because residual crystallization in the microplate can cause negative controls to show out of range results. This could lead to inaccurate test outcomes.
Residual crystallization in the microplate can cause negative controls to show out of range results. This may lead to inaccurate test outcomes, potentially affecting diagnostic accuracy.
Users of the ZYMUTEST HIA MonoStrip IgG ELISA kit (Model RK041A) for in vitro diagnostics are affected. Laboratory personnel and healthcare providers using this specific kit are most at risk.
Check for the model number RK041A on the kit packaging. Affected kits were sold with serial numbers F1701084 or F1900611.
Verify if your kit has serial numbers F1701084 or F1900611.
The recall is due to residual crystallization in the microplate causing negative controls to go out of range, which may lead to inaccurate test results.
Check if your kit has serial numbers F1701084 or F1900611. If so, stop using it and contact Aniara Diagnostica for guidance.
The recall record does not mention 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-2346-2019 — Aniara Diagnostica Aniara Diagnostica Hello, I own a Aniara Diagnostica that is covered by recall Z-2346-2019 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.
