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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,120DXsee related information
Date Initiated by FirmMarch 24, 2006
Date PostedAugust 03, 2006
Recall Status1 Terminated 3 on May 23, 2012
Recall NumberZ-1334-06
Recall Event ID 35719
510(K)NumberK022200 K050719 
Product Classification automated hematology analyzer - Product Code GKZ
ProductABX Pentra 120,120R,120DX, automated hematology analyzer
Code Information All serial numbers, all software versions.
FEI Number 3002698356
Recalling Firm/
Manufacturer		 ABX Diagnostics Inc
34 Bunsen
Irvine CA 92618-4210
For Additional Information ContactCarl 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
ActionNotifications 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.
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GKZ
510(K)s with Product Code = GKZ
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