Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The Recalled by Abbott Laboratories Due to Devices were delivered without the required dry ice.

Date: April 9, 2019
Company: Abbott Laboratories
Status: Terminated
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 High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.

Quantity: 3 units

Why Was This Recalled?

Devices were delivered without the required dry ice.

Where Was This Sold?

Distribution to Latvia.

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