Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0645-2013 — ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

U.S. FDA — Device Enforcement · United States · 2012-09-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0645-2013
Date of alert
2012-09-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Horiba Instruments, Inc dba Horiba Medical
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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