The Recall Desk

FDA (Devices) recall action 80684

Euro Diagnostica AB recalled 4 products on 2018-08-29

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-08-29
Critical
0
Units
20

Why these products were recalled

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • LowFDA (Devices)··2018-08-29

    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.

    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…
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-08-29

    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'.

    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…
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-08-29

    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.'

    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…
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-08-29

    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.

    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…
    Category
    Distribution
    1 state