Aniara ZYMUTEST HIA MonoStrip IgG ELISA kit recalled for quality issues
Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 describes quality control failures (crystallization and out-of-range controls) without reporting any specific patient injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. The recall was initiated because of residual crystallization of the microplate and recurrent negative controls 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 codes associated with this recall are F1701084 and F1900611.
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, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
- Manufacturer
- Aniara Diagnostica LLC
- Affected units
- 51
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 (2)
- F1701084
- F1900611
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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