Reported Aug 29, 2018 · Terminated
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific…
Euro Diagnostica AB
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Euro Diagnostica AB · Box 50117 · Malmo · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Lot #'s: TS2725 (kit) and TS 2733 (PC)
- Amount recalled
- 4
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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