Euro Diagnostica Immunoscan CCPlus Test Kits Recalled for Decreasing Performance
Euro Diagnostica AB is recalling 25 Immunoscan CCPlus test kits due to decreasing performance over time. The kits were distributed in Minnesota, Texas, and Iran.
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, but the source text does not report any hospitalizations, significant injuries, or property damage, aligning with the Moderate severity criteria for low-risk issues or voluntary precautionary actions.
Plain-English summary
Euro Diagnostica AB is recalling 25 units of the Immunoscan CCPlus test kit. This product is an enzyme-linked immunosorbent assay (ELISA) used for the qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The recall is being conducted because the kits exhibit decreasing performance over time.
The affected units are identified by Lot # RS 3092 and SS 1737. Distribution of these specific kits was limited to Minnesota and Texas in the United States, as well as Iran. The recall number is Z-2918-2018.
Consumers and healthcare facilities should stop using the affected test kits and contact Euro Diagnostica AB for instructions on return or replacement. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
- Manufacturer
- Euro Diagnostica AB
- Hazard
- Affected units
- 25
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)
- Lot # RS 3092
- SS 1737
Distribution
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