FDA Device Intelligence
Home › EUROIMMUN Medizinische Labordiagnostika AG › Anti-Sm ELISA (IgG)

Anti-Sm ELISA (IgG)

EUROIMMUN Medizinische Labordiagnostika AG · Model EA 1593-9601 G · UDI-DI 04049016027027

LKP
1
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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.