Aniara Diagnostica Recalls ZYMUTEST HIA MonoStrip ELISA Kits
Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Aniara Diagnostica LLC is recalling 46 units of the ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D. The product is intended for in vitro diagnostic use. The recall was initiated because of residual crystallization of the microplate and recurrent negative controls that were out of range.
The affected products were distributed to the US states of North Carolina, New Hampshire, New York, and Ohio, as well as to Sweden. The specific lot code for the recalled items is F1701571.
Consumers and healthcare facilities should stop using the affected kits and contact the recalling firm for further instructions.
The recalled product
- Product
- ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
- Manufacturer
- Aniara Diagnostica LLC
- Hazard
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- F1701571
Distribution
Part of a larger recall action
This product is one of 2 recalled by Aniara Diagnostica LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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