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Terminated

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, particularly Sjgren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

FDA Recall Z-2919-2018 · Posted 2018-08-23

Recalling FirmEuro Diagnostica AB
Recall StatusTerminated
Product CodeLKO
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.

K905194DIASTAT ANTI-RO (SS-A)Shield Diagnostics, Ltd. · 1990-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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