Euro Diagnostica Scl-70 ELISA Kits Recalled for Labeling Error
Euro Diagnostica AB is recalling four Scl-70 ELISA kits due to incorrect distribution labeling. The kits were manufactured by DiaSorin but incorrectly labeled as manufactured by them.
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, which is a documentation issue unlikely to cause adverse health consequences.
Plain-English summary
Euro Diagnostica AB is recalling four units of the Scl-70 ELISA kit, a qualitative indirect enzyme immunoassay used to detect antibodies specific for the Scl-70 antigen in human serum or plasma. The test is intended as an aid to the diagnosis of scleroderma. The recall is due to a labeling error where the kits were incorrectly labeled as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'
The affected products are identified by Lot # TS 1740 (kit) and Lot # TS 1743 (PC). The distribution pattern is listed as MN. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected kits and contact Euro Diagnostica AB for further instructions or replacement. The error is strictly administrative and does not affect the performance or safety of the diagnostic test itself.
The recalled product
- Product
- is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in…
- 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: TS 1740 (kit) and TS 1743 (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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