Diastat Anti-Nuclear Antibody (Ana) Kit

• • Terminated Z-2627-2017 FDA Class III ·initiated 22 May 2017

  FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.

• • Terminated Z-0306-2018 FDA Class II ·initiated 14 Feb 2017

  Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.

• • Terminated Z-0929-2018 FDA Class II ·initiated 15 Oct 2015

  Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.

510(k) Number

K932876 ↗

FDA Product Code

LKJ

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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