FDAClass IIFebruary 7, 2018

10 ML Reagent CUP recall

10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

Why was 10 ML Reagent CUP recalled?

The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

DATE - MVT 25.08.2017

Product
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Recalling firm
Horiba Instruments, Inc dba Horiba Medical
Quantity
10 bags, 100 units each
Distribution
Nationwide
Recall date
February 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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