Aniara Diagnostica recalls ZYMUTEST HIA MonoStrip IgGAM ELISA kit (Model RK041D) for in vitro diagnostic use due to residual crystallization causing negative controls to go out of range. Affected users should contact for details.
Residual crystallization of the microplate and recurrent negative controls out of range.
Aniara Diagnostica is recalling their ZYMUTEST HIA MonoStrip IgGAM ELISA kit (Model RK041D) because it can cause negative controls to show out of range due to residual crystallization. This affects lab users who rely on this test kit for in vitro diagnostics.
The kit can develop residual crystallization in the microplate, which causes negative controls to show out of range. This means the test results might be inaccurate, but it does not cause physical harm or immediate danger.
Lab users who purchased the ZYMUTEST HIA MonoStrip IgGAM ELISA kit (Model RK041D) for in vitro diagnostics are most at risk. This recall does not affect the general public.
Check for the model number RK041D on the kit's packaging. This product is for in vitro diagnostic use and was sold under the brand Aniara Diagnostica.
Reach out to Aniara Diagnostica for specific instructions on how to handle the recalled kit.
No, the hazard is a potential for inaccurate test results due to residual crystallization, not physical harm.
Look for the model number RK041D on the kit's packaging. This product is for in vitro diagnostic use.
Contact Aniara Diagnostica for specific instructions on handling the recalled kit.
We’ve drafted a message you can send Aniara Diagnostica to request your refund or repair — edit it as you like.
Subject: Recall Z-2347-2019 — Aniara Diagnostica Aniara Diagnostica Hello, I own a Aniara Diagnostica that is covered by recall Z-2347-2019 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.
