Drug recall
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
FDA recall event 78692 · Class II · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Event ID | 78692 |
|---|---|
| Recall numbers | Z-0493-2018, Z-0494-2018 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Product type | Devices |
| Products | 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400, 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to… |
| Initiation date | Nov 21, 2017 |
| Report date | Feb 7, 2018 |
| Termination date | Nov 4, 2019 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3002698356 |
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: