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

Recall Insight

This FDA Devices action (record #Z-1075-2013) was formally reported on April 17, 2013, with the manufacturer initiating the action on August 18, 2010. It is classified under Low severity (Class III), with a current status of Terminated. Tosoh Bioscience Inc is listed as the recalling firm, operating out of Grove City, OH. Federal records indicate 633 units are affected.

The documented reason for this recall is: 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. T… Distribution data in the federal record shows the product reached: 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,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.