FDA recall Z-2920-2018

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 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

Reason for recall

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

Distribution

MN

Key facts

Status

Terminated

Initiation date

2016-10-21

Report date

2018-08-29

Termination date

2019-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malmo, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2920-2018