Euro Diagnostica AB: Medical Device Recall in 2018 - (Recall #: Z-2921-2018)

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 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 autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.

Product Classification:

Class III

Date Initiated: October 21, 2016

Date Posted: August 29, 2018

Recall Number: Z-2921-2018

Event ID: 80684

Reason for Recall:

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

Status: Terminated

Product Quantity: 6

Code Information:

Lot #'s: TS 2819 (kit) and TS 2841 (PC)

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated