Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error
Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits due to an incorrect distribution label. The kits were distributed in Minnesota.
What this means for you
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, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the distributor name.
Plain-English summary
Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits. These kits are used to detect IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and plasma. The recall is due to a labeling error where the kits were incorrectly marked as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'
The affected lots are TS 2819 (kit) and TS 2841 (PC). The recall is limited to Minnesota. No illnesses or injuries have been reported in connection with this labeling error.
Healthcare providers and laboratories should stop using the affected lots and contact Euro Diagnostica AB for further instructions.
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 anti-cardiolipin IgM autoantibod
- 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 2819 (kit) and TS 2841 (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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