FDA-Device2013-01-16Class II
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Horiba Instruments, Inc dba Horiba Medical
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
Sold states
Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.
Affected count
10 units
Manufactured in
34 Bunsen, Irvine, CA, United States
Products
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0645-2013Don't want to check this manually?
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