FDA recall Z-2922-2018

Euro Diagnostica AB · Class III · device

Product

is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma 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-2922-2018