FDA Device recall Z-2117-2020
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose…
- FDA Device
- Class II
- ongoing
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose… by Abbott And Kg, citing 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 proc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2117-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-04-24 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott And Kg |
| Distribution | US |
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.
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2117-2020%22
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