Euro Diagnostica AB: Medical Device Recall in 2018 - (Recall #: Z-2919-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

Product Classification:

Class III

Date Initiated: October 21, 2016

Date Posted: August 29, 2018

Recall Number: Z-2919-2018

Event ID: 80684

Reason for Recall:

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

Status: Terminated

Product Quantity: 4

Code Information:

Lot #'s: TS2725 (kit) and TS 2733 (PC)

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated