Recall Z-2117-2020— Abbott Gmbh & Co. KG

Name: FDA recall Z-2117-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-24

Class II · Ongoing

Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2020-04-24. It names one FDA 510(k) clearance: K102699. 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.. Reason: 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..

Recalling firm: Abbott Gmbh & Co. KG
Classification: Class II
Status: Ongoing
Initiated: 2020-04-24
Firm location: Wiesbaden, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSAbbott Laboratories·cleared 2011-04-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.