Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error
Euro Diagnostica AB is recalling Anti-Cardiolipin ELISA kits due to incorrect labeling. The kits were incorrectly labeled as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a minor labeling error regarding the distributor's role, which is unlikely to cause adverse health consequences.
Plain-English summary
Euro Diagnostica AB is recalling six units of the Anti-Cardiolipin ELISA kit. This product is a quantitative and qualitative enzyme-linked immunosorbent assay (ELISA) used to detect IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and plasma. The recall is limited to specific lots: TS 2783 (kit) and TS 2787 (PC).
The recall was initiated because the product was incorrectly labeled. The label stated 'Manufactured by DiaSorin,' but the correct term should be 'Distributed by DiaSorin.' This is a documentation and labeling issue rather than a defect in the test's performance or safety.
The affected units were distributed in Minnesota. Healthcare facilities and laboratories that possess these specific lots should stop using the kits and contact the recalling firm for instructions on return or disposal. No illnesses or injuries have been reported in connection with this labeling error.
The recalled product
- Product
- is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG…
- Manufacturer
- Euro Diagnostica AB
- Hazard
- Affected units
- 6
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 #'s: TS 2783 (kit) and TS 2787 (PC)
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Euro Diagnostica AB 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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