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DIASTAT anti-Sm/RNP

Svar Life Science AB · Model FRNP200 · UDI-DI 07340058410028

LKP
10
510(k) clearances
0
Adverse events
1
Recalls
14
Facilities

Recalls

DateFirmReason
2015-12-28Phadia AbAll equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investiga

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.