Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ARCHITECT STAT Troponin-I Reagent Kit Recalled by Abbott Laboratories Due to One lot of reagent was manufactured with insufficient...

Date: July 26, 2022
Company: Abbott Laboratories
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Laboratories directly.

Affected Products

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

Quantity: 2451 kits of 100 tests

Why Was This Recalled?

One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Laboratories

Abbott Laboratories has 124 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report