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U.S. Department of Health and Human Services

Class 2 Device Recall The ABX PENTRA 400 / PENTRA C400 Reagent Container (10 mL)

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  Class 2 Device Recall The ABX PENTRA 400 / PENTRA C400 Reagent Container (10 mL) see related information
Date Initiated by Firm November 21, 2017
Create Date January 31, 2018
Recall Status1 Terminated 3 on November 04, 2019
Recall Number Z-0493-2018
Recall Event ID 78692
510(K)Number K052007  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Code Information DATE - MVT 25.08.2017
Recalling Firm/
Manufacturer
Horiba Instruments, Inc dba Horiba Medical
34 Bunsen
Irvine CA 92618-4210
For Additional Information Contact
949-453-0500 Ext. 208
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Process control
Action The firm initiated their recall by letter on 11/21/2017. The letter stated the following: "A new production of reagent container compliant for each reference is under process and will be made available very soon. In the meantime and to allow a proper operating of the analyzer ABX PENTRA 400 / PENTRA C400, it Is necessary to push the reagent containers in the reagent racks until they touch the bottom of the rack. Please share this information with your laboratory staff, and retain this notification as part of your Quality System documentation. It is mandatory for you to complete and return the enclosed response form within 10 days so we may maintain our records."
Quantity in Commerce 10 bags, 100 units each
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = HORIBA ABX
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