Drug recall
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data…
FDA recall event 64386 · Class III · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Event ID | 64386 |
|---|---|
| Recall numbers | Z-1050-2013 |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Product type | Devices |
| Products | ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions. |
| Initiation date | Feb 15, 2013 |
| Report date | Apr 10, 2013 |
| Termination date | Aug 11, 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
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: