Recall Z-0929-2018
Euro Diagnostica AB · initiated October 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
Codes / lots: UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Euro Diagnostica sent a Customer notifications letter to affected customers via email on 10/15/2015. The letter identified the affected product problem and actions to be taken. For question contact Euro Diagnostica .
Details
- Recall number
- Z-0929-2018
- Initiated
- October 15, 2015
- Terminated
- March 29, 2019
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Quantity
- 1090
- Distribution
- Worldwide Distribution and US. Nationwide
- Recalling firm
- Euro Diagnostica AB, Malmo