Abbott Gmbh & Co. KG recalls ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of…

Recall date

April 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2117-2020

FDA classification

Class II

Brand / firm

Abbott Gmbh & Co. KG

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, ND, NE, NJ, NV, NY, OH, OK, PA, RI, SC, TN,TX, UT, VA, VT, WA, WI, PR. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Bar…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.