Malmo, Sweden
Euro Diagnostica AB recalls
4 recalls recorded since 2018, most recently on 14 February 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 February 2017
- Terminated
- 16 May 2018
- Reason
- Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
- Distribution
- MN, NE, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0306-2018
- Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific an
Terminated Class III Medical devices
- Recall started
- 21 October 2016
- Terminated
- 5 November 2019
- Reason
- Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
- Distribution
- MN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2919-2018, Z-2920-2018, Z-2922-2018, Z-2921-2018
- 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 inte
- 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 plasm
- 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
- 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 plasm
Terminated Class II Medical devices
- Recall started
- 14 February 2016
- Terminated
- 5 November 2019
- Reason
- Decreasing performance overtime.
- Distribution
- Minnesota and Texas Foreign: Iran
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2918-2018
- Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
Terminated Class II Medical devices
- Recall started
- 15 October 2015
- Terminated
- 29 March 2019
- Reason
- Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.
- Distribution
- Worldwide Distribution and US. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0929-2018
- DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detect
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.