medical Class II Updated 2020-06-03

Abbott Gmbh & Co. KG recalls ARCHITECT iGentamicin Reagent Kit - Product Usage: The measu

Recalled Product

ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.


Hazard / Issue

Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: MODEL: 1P31-25 LOT NUMBERS: 04281BE00, 08510BE00 and 11221BE00 Shelf life per LOT: 04281BE00;2020-MAY-21 08510BE00; 2020-AUG-08 11221BE00;2020-NOV-18
View official government recall

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