Drug recall
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
FDA recall event 75727 · Class II · Tosoh Bioscience, Inc.
Key facts
| Event ID | 75727 |
|---|---|
| Recall numbers | Z-1225-2017 |
| Recalling firm | Tosoh Bioscience, Inc. |
| Product type | Devices |
| Products | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of… |
| Initiation date | Nov 7, 2016 |
| Report date | Mar 1, 2017 |
| Termination date | Feb 9, 2021 |
| City | South San Francisco |
| State | CA |
| Country | United States |
| FEI number | 1000123732 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: