Drug recall
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated…
FDA recall event 80257 · Class II · Tosoh Bioscience Inc
Key facts
| Event ID | 80257 |
|---|---|
| Recall numbers | Z-2745-2018 |
| Recalling firm | Tosoh Bioscience Inc |
| Product type | Devices |
| Products | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on… |
| Initiation date | Jun 6, 2018 |
| Report date | Aug 22, 2018 |
| Termination date | Feb 9, 2021 |
| 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: