Drug recall
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707…
FDA recall event 63536 · Class III · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Event ID | 63536 |
|---|---|
| Recall numbers | Z-0289-2013 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Product type | Devices |
| Products | ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using… |
| Initiation date | Sep 14, 2012 |
| Report date | Nov 21, 2012 |
| Termination date | Nov 29, 2012 |
| 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: