Recall Z-2922-2018— Euro Diagnostica AB

Name: FDA recall Z-2922-2018
Creator: U.S. Food and Drug Administration
Published: 2016-10-21

Class III · Terminated

Class III FDA medical device recall by Euro Diagnostica AB, initiated 2016-10-21, terminated 2019-11-05. It names one FDA 510(k) clearance: K912291. 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: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin..

Recalling firm: Euro Diagnostica AB
Classification: Class III
Status: Terminated
Initiated: 2016-10-21
Terminated: 2019-11-05
Firm location: Malmo, Sweden

510(k) clearances named in this recall

1 on FDA's record

K912291 — DISTAT ANTI-SCL-70 KITShield Diagnostics, Ltd.·cleared 1991-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.