Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to False Positives
Euro Diagnostica is recalling 1,090 units of DIASTAT ANA ELISA kits because high background levels may cause false positive test results.
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 hazard involves diagnostic test inaccuracy (false positives) rather than direct physical injury or contamination, fitting the Moderate severity criteria for low-risk issues.
Plain-English summary
Euro Diagnostica AB is recalling 1,090 units of the DIASTAT anti-Nuclear antibody (ANA) ELISA test, catalog number FANA200. The affected lots are SS 1500 and SS 2009, identified by UDI 07340058410486. These products were distributed worldwide and nationwide in the United States.
The recall was initiated after a complaint investigation determined that specific product characteristics, including high background in the ELISA plate, a strong IgM conjugate, and a low reference control, increased the risk of equivocal or false positive sample test results. Although the product met quality requirements at the time of lot release, these factors compromise the reliability of the test outcomes.
The DIASTAT ANA ELISA is a qualitative test used to detect anti-nuclear antibodies in human serum or EDTA plasma. It is used to screen samples for various ANAs, including those against Sm, Ro, La, Scl-70, Jo-1, dsDNA, histone, and centromere antigens. Users of these specific lots should stop using the kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs a
- Manufacturer
- Euro Diagnostica AB
- Affected units
- 1,090
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)
- UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009.
Distribution
Distributed nationwide across the United States.
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