Recall Z-2627-2017
Euro Diagnostica AB · initiated May 22, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) 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.
Codes / lots: TS 3577
Reason for recall
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.
FDA-determined cause: Other
Action taken
The firm initiated the problem by email on 05/22/2017. The consignee was directed to destroy the product.
Details
- Recall number
- Z-2627-2017
- Initiated
- May 22, 2017
- Terminated
- March 31, 2021
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Quantity
- 501 units
- Distribution
- MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada
- Recalling firm
- Euro Diagnostica AB, Malmo