Aniara Diagnostica ZYMUTEST HIA MonoStrip Kit Recall: Residual Crystallization Risk
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.
Lower-risk recall
Residual crystallization of the microplate and recurrent negative controls out of range.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/67380-aniara-diagnostica-zymutest-hia-monostrip-kit-recall-residual-crystallization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/67380-aniara-diagnostica-zymutest-hia-monostrip-kit-recall-residual-crystallization-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2346-2019
Cite this page
“Aniara Diagnostica ZYMUTEST HIA MonoStrip Kit Recall: Residual Crystallization Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67380-aniara-diagnostica-zymutest-hia-monostrip-kit-recall-residual-crystallization-risk. Based on FDA recall #Z-2346-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2346-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for the model number RK041A on the kit packaging. Affected kits were sold with serial numbers F1701084 or F1900611.
- Brand
Aniara Diagnostica- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distribution to US states of NC, NH, NY, and OH, and Sweden.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2346-2019 | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.; F1701084, F1900611 | 51 |
| Z-2347-2019 | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.; F1701571 | 46 |
What to do — step by step
Check Kit Serial Numbers
Verify if your kit has serial numbers F1701084 or F1900611.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
FDA distribution: “Distribution to US states of NC, NH, NY, and OH, and Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Hampshire, New York, North Carolina, Ohio.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2346-2019 (July 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2346-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.