Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation
Euro Diagnostica is recalling 534 DIASTAT ANA ELISA kits (Lot TS 2076) distributed in Minnesota, Nebraska, and Texas because a component deviation may cause false positive results.
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. The hazard involves potential false positive results rather than direct physical injury or death, fitting the criteria for moderate severity involving low-risk contamination or performance issues without reported harm.
Plain-English summary
Euro Diagnostica AB is recalling 534 units of the DIASTAT ANA (anti-nuclear antibody) ELISA kit, specifically Lot TS 2076. The recall was initiated after the manufacturer identified a deviation in one of the kit's components.
The affected kits may not perform correctly, which could potentially yield false positive test results. A positive ANA test result provides presumptive evidence for systemic rheumatic disease, so inaccurate results could impact the diagnostic process.
The recalled kits were distributed in Minnesota, Nebraska, and Texas. The source text does not specify further instructions for consumers or healthcare providers regarding the disposal or return of these kits.
The recalled product
- Product
- Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic…
- Manufacturer
- Euro Diagnostica AB
- Affected units
- 534
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)
- Lot: TS 2076
Distribution
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