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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Distribution
Distributed nationwide across the United States.
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