Z-2627-2017 Class III Terminated
FDA device recall Z-2627-2017 was initiated by Euro Diagnostica AB on May 22, 2017 and is designated Class III. 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… The recall status is terminated (terminated March 31, 2021). Affected quantity: 501 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- May 22, 2017
- Termination Date
- March 31, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 501 units
Product Description
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.
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.
Distribution Pattern
MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada
Code Information
TS 3577