FDA Enforcement
Class III
Terminated
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Recall: Z-2919-2018
·
Reported August 29, 2018
Enforcement
- Recall Number
- Z-2919-2018
- Event ID
- 80684
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Euro Diagnostica AB
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 29, 2018
- Initiation Date
- October 21, 2016
- Classification Date
- August 23, 2018
- Termination Date
- November 5, 2019
- Address
- Box 50117, Lundavagen 151, Malmo, N/A, Sweden
Description
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Reason
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Code Info
Lot #'s: TS2725 (kit) and TS 2733 (PC)
Distribution
MN
Quantity
4