Manufacturer

Euro Diagnostica AB

8 recalls in our database name Euro Diagnostica AB as the manufacturing or recalling firm.

What the numbers show

Total: 8
Critical: 0
Severe: 0
Most recent: 2018-08-29

Of the 8 recalls from Euro Diagnostica AB we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

ModerateFDA (Devices)·Z-2918-2018·2018-08-29
Euro Diagnostica Immunoscan CCPlus Test Kits Recalled for Decreasing Performance
Euro Diagnostica AB is recalling 25 Immunoscan CCPlus test kits due to decreasing performance over time. The kits were distributed in Minnesota, Texas, and Iran.
Product
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.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-2919-2018·2018-08-29
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 diseases,
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2922-2018·2018-08-29
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 isolation.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2921-2018·2018-08-29
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 autoantibod
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2920-2018·2018-08-29
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 autoanti
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0929-2018·2018-03-14
Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to False Positives
Euro Diagnostica is recalling 1,090 units of DIASTAT ANA ELISA kits because high background levels may cause false positive test results.
Product
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 detection of ANAs in human serum or EDTA plasma. It detects ANAs a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0306-2018·2018-01-10
Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation
Euro Diagnostica is recalling 534 DIASTAT ANA ELISA kits (Lot TS 2076) distributed in Minnesota, Nebraska, and Texas because a component deviation may cause false positive results.
Product
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 antibody profiles is a valuable aid in the diagnostic process.
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-2627-2017·2017-07-05
Euro Diagnostica Recalls DIASTAT ANA Kits Due to Incorrect Expiration Date
Euro Diagnostica AB is recalling 501 units of DIASTAT ANA kits because the packaging displayed the original expiration date instead of the shortened one.
Product
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), S
Category
Medical Device
Distribution
4 states