FDA Device Intelligence
HomeDevice types › LER

Fluorescent Immunoassay, Theophylline

FDA product code LER · Class 2 · Clinical Toxicology

0
Registered devices
0
Adverse events
1
Recalls
15
510(k) clearances

Recent recalls

DateFirmReason
2007-04-11Abbott Diagnostic International, Ltd.A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the followin

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
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.