Class III — Tosoh Bioscience Inc
| Recalling firm | TOSOH BIOSCIENCE |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| 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. |
| Product | G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood. |
| Quantity | 633 |
| Distribution | 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. |
| Initiated | 2010-08-18 |
| Classified | 2013-04-09 |
| Terminated | 2014-05-13 |
| Recall number | Z-1075-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Tosoh Bioscience Inc (Z-1075-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/56584/
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