The Recall Desk
HighFDA (Devices)·Z-1660-2022·Announced 2022-09-07

ARCHITECT STAT Troponin-I Reagent Kit Recalled for Insufficient Blocking Agents

Abbott is recalling one lot of ARCHITECT STAT Troponin-I Reagent Kits due to insufficient heterophilic blocking agents in the conjugate, which may affect test accuracy.

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: FDA Class II recall of a diagnostic reagent with a manufacturing defect affecting a functional component. No reported illnesses or injuries. Fits the criterion 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Abbott Laboratories is recalling lot 63718UN22 of the ARCHITECT STAT Troponin-I Reagent Kit (REF 2K41-27). This lot consists of 2,451 kits, each containing 100 tests. The product was distributed nationwide.

The recalled lot was manufactured with insufficient quantities of heterophilic blocking agents in the conjugate component. These blocking agents are essential components of the reagent system.

This reagent kit is used in clinical laboratories for troponin-I testing, which is a cardiac biomarker measured to aid in the diagnosis of heart conditions. The deficiency in blocking agents may compromise the reliability and accuracy of test results.

The recall affects clinical laboratories, hospitals, and diagnostic testing facilities that received kits from the affected lot and are using them for patient testing.

The recalled product

Product
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Manufacturer
Abbott Laboratories
Category
Medical Device — In-Vitro Diagnostic Reagent
Hazard
  • blocking-agent-deficiency
  • diagnostic-error

Distribution

Distributed nationwide across the United States.

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