Euro Diagnostica Anti-Ro ELISA Kits Recalled for Incorrect Labeling
Euro Diagnostica is recalling Anti-Ro (SS-A) ELISA kits due to incorrect labeling. The label incorrectly states '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, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the manufacturer's role.
Plain-English summary
Euro Diagnostica AB is recalling four units of Anti-Ro (SS-A) ELISA kits. The product is a quantitative/qualitative enzyme-linked immunosorbent assay used to detect autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sjögren's syndrome.
The recall was initiated because the product labeling is incorrect. The label currently states 'Manufactured by DiaSorin,' but the correct term should be 'Distributed by DiaSorin.' The affected lot numbers are TS2725 (kit) and TS 2733 (PC). The distribution pattern is listed as MN.
No specific instructions for consumers are provided in the source text. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic…
- Manufacturer
- Euro Diagnostica AB
- Hazard
- Affected units
- 4
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: TS2725 (kit) and TS 2733 (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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