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.
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-2922-2018
- 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: TS 1740 (kit) and TS 1743 (PC)
Root Cause
Error in labeling
Action Taken
none
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