Euro Diagnostica AB: Medical Device Recall in 2018 - (Recall #: Z-2922-2018)

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 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.

Product Classification:

Class III

Date Initiated: October 21, 2016

Date Posted: August 29, 2018

Recall Number: Z-2922-2018

Event ID: 80684

Reason for Recall:

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

Status: Terminated

Product Quantity: 4

Code Information:

Lot #'s: TS 1740 (kit) and TS 1743 (PC)

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated