FDA Device recall Z-1075-2013
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood
- FDA Device
- Class III
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class III recall of G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood by Tosoh Bioscience, citing 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 qua….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1075-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2010-08-18 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
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.
Identifiers
| code_info | 11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206…11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1075-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.