Enforcement Report - Week of January 16, 2013
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Event Detail
| Event ID | 63829 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Horiba Instruments, Inc dba Horiba Medical |
| City | Irvine |
| State | CA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide in the US, including the states of CA, MI, IN, FL, and GA. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 | Lot/Serial# PML0937 | Class II | Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software versions are Versions 9.0.1, 9.0.2, 8.0x and below. | 10 units | Z-0645-2013 |
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