Drug recall
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of…
FDA recall event 81188 · Class III · Tosoh Bioscience Inc
Key facts
| Event ID | 81188 |
|---|---|
| Recall numbers | Z-0601-2019 |
| Recalling firm | Tosoh Bioscience Inc |
| Product type | Devices |
| Products | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and… |
| Initiation date | Oct 5, 2018 |
| Report date | Dec 19, 2018 |
| Termination date | Jun 16, 2020 |
| City | Grove City |
| State | OH |
| Country | United States |
| FEI number | 3005529799 |
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: