Drug recall
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High)…
FDA recall event 63539 · Class III · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Event ID | 63539 |
|---|---|
| Recall numbers | Z-0429-2013 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Product type | Devices |
| Products | Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer… |
| Initiation date | Sep 14, 2012 |
| Report date | Nov 28, 2012 |
| Termination date | Apr 22, 2013 |
| 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: