Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

G7 HPLC. Used as an aid in the detection and Recalled by Tosoh Bioscience Inc Due to The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia...

Date: August 18, 2010
Company: Tosoh Bioscience 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 Tosoh Bioscience Inc directly.

Affected Products

G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.

Quantity: 633

Why Was This Recalled?

The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be detected with the G7 Beta-thalessemia columns.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tosoh Bioscience Inc

Tosoh Bioscience Inc has 68 total recalls tracked by RecallDetector.

Related Recalls

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