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

Recall Z-0904-2014 — ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.

U.S. FDA — Device Enforcement · United States · 2013-11-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0904-2014
Date of alert: 2013-11-21
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 the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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-0904-2014 — ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.

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