Date Initiated by Firm | November 13, 2014 |
Date Posted | January 02, 2015 |
Recall Status1 |
Terminated 3 on March 19, 2015 |
Recall Number | Z-0902-2015 |
Recall Event ID |
69773 |
510(K)Number | K052007 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) |
Code Information |
Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014. |
Recalling Firm/ Manufacturer |
Horiba Instruments, Inc dba Horiba Medical 34 Bunsen Irvine CA 92618-4210
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For Additional Information Contact | 949-453-0500 Ext. 208 |
Manufacturer Reason for Recall | HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they 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. The defect would result in a
false high or false low results for HbA1c and false high results for magnes |
FDA Determined Cause 2 | Package design/selection |
Action | A recall letter was sent on 11/13/14 to all customers who purchased the ABX PENTRA 400 Clinical Chemistry Analyzer. The letter informs the customer of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact their local HORIBA Medical representative. |
Quantity in Commerce | 443 units |
Distribution | Nationwide in US |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JJE
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