The Recall Desk
HighFDA (Devices)·Z-2117-2020·Announced 2020-06-03

Abbott Recalls Architect iGentamicin Reagent Kits Due to Assay Interaction

Abbott is recalling 6,087 Architect iGentamicin Reagent Kits because they may interact with troponin assays, potentially impacting patient results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a potential interaction could impact patient results, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Abbott GmbH & Co. KG is recalling 6,087 units of the ARCHITECT iGentamicin Reagent Kit (Model 1P31-25). The affected lot numbers are 04281BE00, 08510BE00, and 11221BE00. These kits are used to measure gentamicin levels for the diagnosis and treatment of overdose and to monitor therapy.

The recall was initiated because Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays may show interaction when processed directly after the ARCHITECT iGentamicin assay. This interaction might impact patient results.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare facilities and laboratories should stop using the affected lots and contact Abbott for further instructions.

The recalled product

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.
Manufacturer
Abbott Gmbh & Co. KG
Category
Medical Device — Laboratory Reagent
Hazard
Affected units
6,087

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Related recalls

Same manufacturer · Abbott Gmbh & Co. KG

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