FDA recall Z-2919-2018

Euro Diagnostica AB · Class III · device

Product

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.

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-2919-2018