Drug recall
ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with…
FDA recall event 69105 · Class II · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Event ID | 69105 |
|---|---|
| Recall numbers | Z-2692-2014 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Product type | Devices |
| Products | ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the… |
| Initiation date | Aug 11, 2014 |
| Report date | Oct 1, 2014 |
| Termination date | Nov 25, 2014 |
| 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
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: