Class II — Potential Health Hazard

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

Data Station AMPLILINK software is an instrument user interface/ data Recalled by Roche Molecular Systems, Inc. Due to Roche Molecular Systems, Inc. has become aware of...

Date: July 16, 2012
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

Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.

Quantity: 884 units

Why Was This Recalled?

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

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