Home / Recalls / Medical Devices
Horiba Instruments, Inc dba Horiba Medical recalls ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Recalled January 16, 2013 · FDA recall Z-0645-2013 · Horiba Instruments, Inc
Hazard
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 · FDA Class II
Units
10 units
Sold at
Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.
Description
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
Product
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Manufacturer(s)
Horiba Instruments, Inc dba Horiba Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →