Z-2922-2018 Class III Terminated
FDA device recall Z-2922-2018 was initiated by Euro Diagnostica AB on October 21, 2016 and is designated Class III. Reason for recall: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. The recall status is terminated (terminated November 5, 2019). Affected quantity: 4.
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)