Class II — Potential Health Hazard

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

ACCU-CHECK FastClix Lancing Device. It is intended for use in Recalled by Roche Diagnostics Operations, Inc. Due to Internal Roche inspections have revealed that after the...

Date: August 19, 2013
Company: Roche Diagnostics Operations, 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 Diagnostics Operations, Inc. directly.

Affected Products

ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

Quantity: 36,332

Why Was This Recalled?

Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.

Related Recalls

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