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

Recall Z-1173-2014 — Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.

U.S. FDA — Device Enforcement · United States · 2014-02-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1173-2014
Date of alert: 2014-02-14
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 initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1173-2014 — Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.

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