Class II — Potential Health Hazard

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

Hand-Held Scanner USB IT3800 For sample identification and tracking when Recalled by Roche Molecular Systems, Inc. Due to The hand-held barcode scanner model IT3800 used with...

Date: March 3, 2016
Company: Roche Molecular Systems, 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 Roche Molecular Systems, Inc. directly.

Affected Products

Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

Quantity: 6,939 pieces

Why Was This Recalled?

The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.

Related Recalls

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