G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
FDA Recall Z-1075-2013 · Posted 2013-04-10
Recalling FirmTosoh Bioscience Inc
Recall StatusTerminated
Product CodeJPD
Date Initiated2010-08-18
Date Terminated2014-05-13
Product Quantity633
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.
Firm Action
Please be aware that this is not a new recall. The firm has taken action. The firm stated that they have notified consignees via mail, with the list of notified customers maintained by the Regulatory Affairs/Quality Assurance department. The firm stated that they have notified distributors in the same way that they have notified other consignees, with a required confirmation to the firm of corrective actions.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.