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. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
FDA Recall Z-2922-2018 · Posted 2018-08-23
Recalling FirmEuro Diagnostica AB
Recall StatusTerminated
Product CodeLKJ
Date Initiated2016-10-21
Date Terminated2019-11-05
Product Quantity4
Reason for Recall
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Firm Action
none
Root Cause
Error in labeling
Distribution Pattern
MN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.