Home › Device 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
| Date | Firm | Reason |
|---|---|---|
| 2007-04-11 | Abbott 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 |
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