Home / Recalls / Euro Diagnostica AB / Z-2922-2018

Z-2922-2018 Class III Terminated

Recalled by Euro Diagnostica AB — Malmo

Recall Details

Product Type
Devices
Report Date
August 29, 2018
Initiation Date
October 21, 2016
Termination Date
November 5, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4

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.

Distribution Pattern

MN

Code Information

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

Other recalls by Euro Diagnostica AB

  • Z-2627-2017 Class III — DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuc (May 22, 2017)
  • Z-0306-2018 Class II — Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti- (February 14, 2017)
  • Z-2921-2018 Class III — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the (October 21, 2016)
  • Z-2919-2018 Class III — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the (October 21, 2016)
  • Z-2920-2018 Class III — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the (October 21, 2016)
  • Z-2918-2018 Class II — Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for q (February 14, 2016)
  • Z-0929-2018 Class II — DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200 (October 15, 2015)