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U.S. Department of Health and Human Services

Class 3 Device Recall ABX Pentra 120,120R,120DX

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  Class 3 Device Recall ABX Pentra 120,120R,120DX see related information
Date Initiated by Firm March 24, 2006
Date Posted August 03, 2006
Recall Status1 Terminated 3 on May 23, 2012
Recall Number Z-1334-06
Recall Event ID 35719
510(K)Number K022200  K050719  
Product Classification automated hematology analyzer - Product Code GKZ
Product ABX Pentra 120,120R,120DX, automated hematology analyzer
Code Information All serial numbers, all software versions.
Recalling Firm/
Manufacturer		 ABX Diagnostics Inc
34 Bunsen
Irvine CA 92618-4210
For Additional Information Contact Carl Levine
949-453-0500 Ext. 208
Manufacturer Reason
for Recall		 Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
FDA Determined
Cause 2		 Other
Action Notifications have been prepared advising that following an occurrence observed outside of the United States, HORIBAABX is providing information regarding the rare circumstance of a label being incorrectly placed on a sample tube, resulting in a possible error in results attributed to a sample. The March 24, 2006, letter identifies various conditions in which the anomaly occurs. In order to prevent this type of incident, the firm recommends that the customer ensure that the identification label is firmly attached to the sample tubes during their positioning or removal from the racks.
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 = GKZ and Original Applicant = ABX DIAGNOSTICS
510(K)s with Product Code = GKZ and Original Applicant = HORIBA ABX
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