Class II — Potential Health Hazard

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

Abbott ARCHITECT Creatine Kinase Recalled by Abbott Laboratories, Inc Due to The product has a stability issue which may...

Date: July 18, 2018
Company: Abbott Laboratories, 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 Abbott Laboratories, Inc directly.

Affected Products

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

Quantity: 30 kits

Why Was This Recalled?

The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Laboratories, Inc

Abbott Laboratories, Inc has 31 total recalls tracked by RecallDetector.

Related Recalls

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