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 Sjgren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
This recall has been terminated (originally issued August 23, 2018).
- Company
- Euro Diagnostica Ab
- Recall Initiated
- October 21, 2016
- Posted
- August 23, 2018
- Terminated
- November 5, 2019
- Recall Number
- Z-2919-2018
- Quantity
- 4
- Firm Location
- Malmo Sweden
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Distribution
MN
Lot / Code Info
Lot #'s: TS2725 (kit) and TS 2733 (PC)
Root Cause
Error in labeling
Action Taken
none
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