Class II — Potential Health Hazard

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

Quidel Triage TOX Drug Screen Control 1 Kit Box containing Recalled by QUIDEL CARDIOVASCULAR INC Due to Due to an error in the programming of...

Date: April 9, 2019
Company: QUIDEL CARDIOVASCULAR INC
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 QUIDEL CARDIOVASCULAR INC directly.

Affected Products

Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com

Quantity: 123 kits

Why Was This Recalled?

Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail.

Where Was This Sold?

This product was distributed to 19 states: AL, AZ, CA, FL, GA, ID, IL, IN, IA, KS, KY, MO, NY, OH, OK, OR, TX, UT, WA

Affected (19 states)Not affected

About QUIDEL CARDIOVASCULAR INC

QUIDEL CARDIOVASCULAR INC has 2 total recalls tracked by RecallDetector.

Related Recalls

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