Recall Z-1075-2013— Tosoh Bioscience Inc

Name: FDA recall Z-1075-2013
Creator: U.S. Food and Drug Administration
Published: 2010-08-18

Class III · Terminated

Class III FDA medical device recall by Tosoh Bioscience Inc, initiated 2010-08-18, terminated 2014-05-13. It names 2 FDA 510(k) clearances: K020489, K011434. Product: G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.. Reason: 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..

Recalling firm: Tosoh Bioscience Inc
Classification: Class III
Status: Terminated
Initiated: 2010-08-18
Terminated: 2014-05-13
Firm location: Grove City, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODETosoh Medics, Inc.·cleared 2002-05-14
K011434 — G7 AUTOMATED HPLC ANALYZERTosoh Medics, Inc.·cleared 2001-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.