Class II — Potential Health Hazard

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

Vysis CLL FISH Probe Kit with the following components: Vysis Recalled by Abbott Molecular, Inc. Due to Potential for Vysis CLL FISH Probe Kits not...

Date: August 4, 2021
Company: Abbott Molecular, 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 Molecular, Inc. directly.

Affected Products

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes

Quantity: 186 units

Why Was This Recalled?

Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Molecular, Inc.

Abbott Molecular, Inc. has 30 total recalls tracked by RecallDetector.

Related Recalls

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