FDAClass IIAugust 31, 2022

HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System recall

HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref…

Why was HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System recalled?

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN: 03610230005514 Lots Distributed:5/30/2021 - 6/9/2021

Product
HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref…
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
3 each
Distribution
US Nationwide
Recall date
August 31, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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