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U.S. Department of Health and Human Services

Class 2 Device Recall ABX PENTRA N Control,

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  Class 2 Device Recall ABX PENTRA N Control, see related information
Date Initiated by Firm November 21, 2013
Date Posted January 31, 2014
Recall Status1 Terminated 3 on October 28, 2014
Recall Number Z-0904-2014
Recall Event ID 66912
510(K)Number K052007  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product 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.

Code Information Lot No. 1300801
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		 Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
FDA Determined
Cause 2		 Under Investigation by firm
Action Horiba sent an customer notification letter dated November 32, 2013, to all affected customers. The letter was sent via email to all customers who purchased the ABX PENTRA 400. HORIBA Medical is informing all ABX PENTRA N Control customers running the Potassium-E assay on the ABX PENTRA 400 with I.S.E. Module that the Target Value and Target Range for Potassium has been updated. The letter informs the customers of the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days by fax (949) 453-0600 Customers with questions are instructed to contact their local HORIBA Medical representative. For further questions please call (949) 453-0500 X 208
Quantity in Commerce 698 units total (80 units in US)
Distribution Worldwide Distribution - USA (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 = JJY and Original Applicant = HORIBA ABX
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